May Newsletter 2022

May Newsletter 2022

EUROPEAN UNION (EU)

Stricter rules for placing medical tests on the market | 25 May 2022

From 26 May 2022, new laws for in vitro diagnostic medical devices (IVDR) such as HIV testing, pregnancy tests, and COVID-19 tests are in effect. The guidelines will improve public health and patient safety for these devices, putting EU law in line with technological advancements and medical research progress. It also ensures equitable market access for manufacturers by unifying market access standards across the EU Member States. 

In summary, the In Vitro Diagnostic Medical Devices Regulation introduces three significant advancements: 

  • In vitro diagnostic medical equipment’s quality, safety, and reliability are improved. 
  • Transparency and information for patients are improved. 
  • Improves market surveillance and vigilance 

Interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 25 May 2022

The Q&A document aims to clarify some of the overlaps between the Clinical Trials for Medicinal Products for Human Use (CTR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Clinical trial experts from the Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the Medical Device Coordination Group (MDCG) collaborated on it. Clinical trial assays can range from CE-marked in vitro diagnostic medical devices (IVDs) to trial- or medicinal product-specific assays that aren’t necessarily aimed at becoming IVDs. This document and the idea of the “medical purpose of an assay in a clinical trial” as a specific context were born out of the necessity to define criteria for these tests.

Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices | 24 May 2022

Switzerland has participated in the European Union’s internal market for in vitro diagnostic medical devices through the EU-Switzerland Mutual Recognition Agreement’s medical devices chapter (MRA). The MRA’s medical devices chapter allows the European Union and Switzerland to recognise conformity assessment certificates based on the equivalence of Directive 98/79/EC on in vitro diagnostic medical devices and Swiss legislation. The parties have been able to trade in vitro diagnostic medical equipment more quickly. 

On 26 May 2022, the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices replaced Directive 98/79/EC. In the absence of an MRA update to incorporate Regulation (EU) 2017/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022. 

Application of IVDR requirements to ‘legacy devices’ and to devices placed on the market before 26 May 2022 | 20 May 2022

The document provides information on the application of IVDR regulations to ‘legacy devices’ and ‘old’ devices since Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), specifically Article 110(3).

Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20 May 2022

The Q&A documentcovers the concerns about the Unique Device Identification system (UDI system), which was established by Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The document intends to give economic operators more information on applying and implementing the UDI requirements.

Summary of Safety and Performance template | 20 May 2022

For class C and D devices, other than devices for performance studies, IVD Regulation (EU) 2017/746 requires the manufacturer to prepare a Summary of Safety and Performance (SSP), which provides public access to an up-to-date summary of the main aspects of the safety and performance of the device. A notified body (NB) must confirm the SSP before it may be made public via the European database on medical devices (EUDAMED). The template can be found here.

New publication of Harmonised standards under the medical devices Regulations | 17 May 2022

The European Commission issued a decision on 11 May 2022, amending the relationship between harmonised criteria for quality management systems, sterilisation, and risk management applications in medical devices. The annex to implementing decision is amended as follows:

  • Entry 10 is replaced by EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
  • EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021
  • The following standards have been added:
  • EN 285:2015+A1:2021 – Sterilisation – Steam sterilisers – Large sterilisers
  • EN ISO 14971:2019 – Medical devices – Application of risk management to medical devices (ISO 14971:2019)
  • EN ISO 14971:2019/A11:2021

Significant changes regarding the transitional provision under Article 110(3) of the IVDR | 04 May 2022

This guidance document aims to clarify the idea of ‘significant changes in the design and intended purpose’ as defined by IVDR Article 110. (3). It applies to manufacturers of devices that comply with Directive 98/79/EC and the devices that are placed on the market or put into operation after 26 May 2022 during the transition period, in line with Article 110(3) IVDR, regardless of whether those devices needed notified body involvement under the IVDD.

AUSTRIA

Clinical investigations with medical devices | 25 May 2022

With the implementation of IVD Regulation (EU) 2017/746, which will regulate the performance studies of in vitro diagnostic medical devices, from 26 May 2022, performance studies must therefore be submitted or reported to the BASG for approval using the updated form, following the requirements of the IVDR. For clinical investigations, the valid submission will then be confirmed. The study can be initiated, followed by a 45-day scientific and regulatory review period.

IRELAND

In Vitro Diagnostic Medical Devices Regulation comes into effect in the EU | 26 May 2022

The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 took effect on 26 May 2022. IVDs are medical devices that use biological samples to do tests to evaluate a person’s health condition. They range from self-tests for pregnancy and blood glucose testing for people with diabetes to complex diagnoses performed in clinical laboratories.

IVDR Transition Timelines | 26 May 2022

The EU Medical Devices Directive 98/79/EC (IVDD) will be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which took effect on 26 May 2022.  The existing transitional timeframes for devices set out in Article 113 of the IVDR are extended by this amendment. The IVDR classification will determine the length of the transition. By 26 May 2022, self-declared IVDs that will not be classified under the IVDR must be IVDR compliant. Below are the transition timelines:

IVDR ClassificationIt may be placed on the market untilCan continue to be made available until
Class D26 May 202526 May 2026
Class C26 May 202626 May 2027
Class B26 May 202726 May 2028
Class A (sterile)26 May 202726 May 2028

In-House Manufactured Devices (IHM) – IVDR Article 5 | 26 May 2022

Article 5(5) of the IVDR outlines the precise criteria and duties that apply to health institutions that manufacture and use IVDs in-house, as long as the device is not transferred to another legal entity. From 26 May 2022, IHM devices will be subject to the general safety and performance criteria outlined in Annex I of the IVDR. However, Regulation 2022/112 defers several IHM device requirements, which are listed in the table below:

IVDR requirementsDescriptionApplicable From
Article 5(5) and Annex IAnnex I applies to in house manufactured devices.26 May 2022
Article 5(5) b, c, and e-iSee Art 5(5) for further details.26 May 2024
Article 5(5)dThe requirement to justify that a patient group’s specific needs cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market.26 May 2028
Article 5(5) final paragraphMember States’ rights to request information/restrict the manufacture and use of devices and inspect health institutions.26 May 2022

HPRA Decision Tree – IVDR Performance Study | 26 May 2022

A decision tree for IVDR performance studies was created to help sponsors determine whether IVDR regulations apply to their research, such as whether an application or notification is necessary. Refer to IVDR Chapter VI for more details.

IVDR Registration Requirements | 26 May 2022

The usage of the EUDAMED database to meet registration obligations is recognised by HPRA. Article 28 of the IVDR outlines the responsibilities of manufacturers, authorised representatives, and importers. To comply with the registration duties, Irish economic operators are encouraged to use the EUDAMED’s actor registration module. By completing the online registration form, distributors, health institutions, and production facilities can register with HPRA.

CZECH REPUBLIC

Information systems in the field of regulation of medical devices | 19 May 2022

The National Medical Device Information System (NISZP) published a document outlining the information systems utilised in the Czech Republic and the European Union to regulate medical devices. The document conveys the following information:

  • the current medical device regulation in the Czech Republic,
  • EUDAMED Database, its modules, and the deadlines
  • UDI
  • Agendas of the Medical Device Information System (ISZP)

The Czech version of the document can be found here.

European Commission implementing decisions on harmonised standards for medical devices published in the Official Journal of the European Union | 17 May 2022

The National Medical Device Information System (NISZP) issued the Czech versions of the EU’s decisions:

  • 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 related to the standards for the quality management systems, and the application of risk management to medical devices

2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 related to the standards for quality management systems, sterilisation, and risk management application to medical devices

FRANCE

European guideline on borderline products | 19 May 2022

Medical Device Coordination Group (MDCG) published guidance for the Borderline Products (Medical Devices and Medicinal Products). Borderline products are those for which it is unsure whether they fall under the MDR or the MPD from the beginning. EU Regulation 2017/745 is used for governing the medical devices in the EU. In contrast, Directive 2001/83/EC regulates the medicinal products for human use (MPD). This document clarifies these regulations with additional explanations and examples to promote the MDR’s consistent application. The publication provides definitions and examples and sections on substance-based devices, plant-based goods, and drug-medical device combinations.

Cosmetics – Production communication | 19 May 2022

Manufacturers of cosmetics shall communicate cosmetics production to the Ministry, either on their own or on behalf of third parties, using the new form made accessible, including extemporaneous manufacturing and small quantities.

Establishment of the national network for supervision | 02 May 2022

The decree for establishing the national network for supervision was published in the official gazette. According to current legislation, public and private health professionals must immediately report any significant accident to the Ministry of Health and the device’s manufacturer. The Ministry of Health then oversees the investigations conducted by the manufacturer or his authorised representative, analysing and monitoring the effectiveness of the corrective actions made. The network was set up to make it easier to share information on events and safety actions involving medical devices, in vitro diagnostic medical devices, and equipment included in Annex XIV of Regulation (EU) 2017/745. The surveillance system is maintained by continuously monitoring medical equipment incidences after being placed on the market. This information system gathers data on the following topics:

  • local supervisor and regional manager contact information
  • incident reports created by healthcare professionals
  • extracts from incident reports provided by manufacturers
  • security measures

RUSSIA

Roszdravnadzor gave recommendations on the operation and use of medical devices connected to the Internet | 19 May 2022

If a medical organisation lacks the resources to employ a secure data transmission network, the medical device must either operate as part of a separated technical network or data should be sent between various components of medical devices employing portable data storage devices. Furthermore, Roszdravnadzor stated that before upgrading the software on a medical device, it is required to ensure the development of backup copies of the software so that it may be restored to its initial state.

Resumption of supplies of imported X-ray film to the Russian Federation | 16 May 2022

The Federal Service for Surveillance in Healthcare held a working meeting with authorised representatives of foreign manufacturers of X-ray film. The daily monitoring of Roszdravnadzor in the country’s regions recorded the defector of this medical product due to the search for new logistics routes by film manufacturers.

The Ministry of Health will study the issue of lifting the ban on the export of medical equipment abroad | 16 May 2022

The Ministry of Health of Russia is working on the issue of lifting the ban on the export of medical equipment from the country for repair as per the First Deputy Minister of Health of Russia, Viktor Fisenko. He highlighted that it is sometimes necessary to export equipment or components for repair overseas. The lifting of such limitations is now being discussed with the Ministry of Economic Development and Roszdravnadzor.

Russia will create a digital service for online medical consultations | 16 May 2022

GLONASS JSC and Polymed will create a telemedicine platform GLONASS Zabota for online consultations with medical specialists, a wide range of laboratory tests, and the order of medicines. This platform will enhance the number of laboratory tests available to citizens of all Russian regions, including those in remote areas, both at stationary and mobile locations with home visits. The service’s users will be able to send the study results to any polyclinic in Russia. Secure data transmission channels of the era-GLONASS state information system will offer the legal meaning of the information, allowing test results to be verified and uploaded to the Unified State Information System in healthcare.

Import substitution in the market of dental materials | 16 May 2022

90% of supplies, tools, and equipment used in private dentistry come from foreign manufacturers. Still, many transactions have become unfeasible due to recent anti-Russian sanctions and logistical issues. Consumables such as dental fillings, braces, mouthguards, and other items have also increased in price. According to experts, Russia has its production. It may replace items from Europe and the United States by refocusing on the Southeast Asian, Chinese, and South Korean markets.

Increase in the production of domestic medical equipment| 12 May 2022

Manufacturers should be aware that, to expand the line and bring domestic products to market as quickly as possible, Roszdravnadzor must reduce the time it takes to issue registration certificates for medical devices, as well as the issuance of certificates of origin of goods and acts of expertise by the Chamber of Commerce and Industry of Russia (CCI). At the same time, medical equipment are already eligible for faster registration under a government directive.

UNITED KINGDOM

Notify the MHRA about a clinical investigation for a medical device | 19 May 2022

All deviations from the study must be reported to the MHRA as soon as the manufacturer becomes aware of them. Details concerning the nature of the deviation, when and where it happened, and any recommended corrective and preventative activities, should be included using the ‘live’ excel template for submitting.

Joint Statement on the launch of the negotiations for a Free Trade Agreement between the UK and Mexico | 20 May 2022

On 20 May 2022, Tatiana Clouthier, Secretary of Economy of the United Mexican States, and Anne-Marie Trevelyan, Secretary of State for the United Kingdom’s Department for International Trade, met in London. They announced the beginning of negotiation for a Free Trade Agreement between the United Mexican States and the United Kingdom in a joint statement. The first official round of the talks will occur in Mexico City in July 2022, followed by a second round in the autumn. This agreement will improve investment flows, strengthen trade in products and services, and encourage digital and cross-border trade.

SWITZERLAND

New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022 | 26 May 2022

The Federal Council adopted the new In-vitro Diagnostic Medical Devices Ordinance (IvDO) and an amendment to the Ordinance on Clinical Trials (CTO-MedD) with Medical Devices on 04 May 2022. The new legal requirements take effect on 26 May 2022, coinciding with the EU’s implementation of the IVDR. Clinical trials with in vitro diagnostic medical devices will be governed by the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) beginning on 26 May 2022, rather than the Ordinance on Clinical Trials (ClinO).

New rules for performance studies | 26 May 2022

Except for performance studies, the provisions of ClinO-MD apply to all performance studies as of 26 May 2022. To assess if a study project must be submitted to Swissmedic, a decision tree for categorising performance studies has been made accessible. Swissmedic and the competent cantonal ethics council must additionally approve performance studies based on this decision tree.

Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices | 25 May 2022

Switzerland has previously participated in the European Union’s internal market for in vitro diagnostic medical equipment under the medical devices chapter of the EU Switzerland Mutual Recognition Agreement (MRA). The medical devices chapter of the MRA provides the acceptance of conformity assessment certificates between the European Union and Switzerland based on the equivalence of Directive 98/79/EC and the applicable Swiss law. However, with the introduction of the new IVD Regulation (EU) 2017/746, the MRA has become obsolete from 26 May 2022, resulting in the following consequences:

  • Swiss in vitro diagnostic medical device manufacturers will be classified as third country manufacturers in the European Union (EU)
  • Conformity assessment bodies established in the EU must certify the conformity assessment procedure
  • Certificates issued under the MRA by Swiss conformity assessment organisations will no longer be recognised as valid in the EU, even if granted before 26 May 2022
  • Swiss manufacturers and third country manufacturers must designate an authorised representative established in the EU for placing the devices on the EU market after 26 May 2022

Medtech in Switzerland 2030 | 17 May 2022

On 17 May 2022, Swiss Medtech announced its vision for “Medtech in Switzerland 2030”, describing methods to maintain Switzerland’s appeal as a Medtech company destination in the future. Stable trade ties, open markets, innovation promotion, and reimbursement schemes tailored explicitly to the Medtech industry were discussed. The reform agenda is essential since the failure of institutional agreement discussions between Switzerland and the European Union (EU) has affected business competitiveness.

Approval of medical devices according to non-European regulatory systems | 06 May 2022

Switzerland only accepts medical devices for national supply that are CE marked and comply with the European Union’s (EU) medical device regulation. Additionally, Switzerland also accepts medical devices from non-European regulatory systems. This is especially true for medical devices that have been approved by the US Food and Drug Administration (FDA).

AUSTRALIA

Seasonal Influenza Rapid Antigen Self-tests and Combination tests | 27 May 2022

The document’s goal is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s (TGA) expectations for clinical performance requirements (clinical sensitivity and specificity) and risk mitigation for in vitro diagnostic medical devices (IVDs) intended for use as self-tests for seasonal influenza and combination tests (for both COVID-19 and Influenza).

Personalised medical device framework | 20 May 2022

TGA uploaded a presentation on the medical device regulations’ overview.

Regulation of software-based medical devices | 03 May 2022

TGA provided provisional guidance to assist manufacturers and sponsors in understanding how the TGA interprets regulations and indicates how they can comply.

Unique Device Identification | 02 May 2022

TGA held a webinar for the Unique Device Identification on 19 April 2022. The presentation of the webinar #8 can be found here. TGA has been undertaking series of webinars on the UDI topics since 2021.

UNITED STATES OF AMERICA (USA)

Revocation of Authorisation of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19 | 24 May 2022

The FDA granted the Broad Institute an Emergency Use Authorization (EUA) for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay on 08 July 2020, subject to the provisions of the Authorisation. Later, on 04 April 2022, the institution requested revocation from the FDA.

Feasibility and early feasibility clinical studies for specific medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus | 06 May 2022

T2DM (Type 2 Diabetes Mellitus) is a metabolic condition characterised by high blood sugar levels, insulin resistance, and insulin deficiency. As a result, several medical device manufacturers and researchers are working to create therapeutic medical devices, including blood glucose monitors and insulin pens, pumps, and syringes, to help patients with T2DM improve their glycemic control. The FDA released a guidance document outlining its initial thoughts on feasibility and early feasibility clinical investigations for these medical devices. These medical devices are designed to lower glycated haemoglobin (HbA1c) levels in T2DM patients without using medications like insulin. Manufacturers are encouraged to submit a Pre-Submission to obtain detailed feedback on the clinical investigation of medical devices within the scope of this guidance that are intended to therapeutically improve glycemic control in patients with T2DM before initiating a pivotal clinical study or to receive additional feedback on the feasibility study design before starting a crucial clinical study.

Voluntary medical device manufacturing and product quality pilot program | 05 May 2022

In 2018, the FDA and the Medical Device Innovation Consortium (MDIC) conducted a voluntary pilot programme among medical device manufacturing sites. MDIC program activities and operations are moving into a permanent program, termed the Case for Quality Voluntary Improvement Program (CfQVIP), based on the pilot’s success. In preparation for the transition to a permanent programme, the FDA and MDIC cooperated to create a charter and a governing committee for CfQVIP. The FDA is currently developing a complementary policy for engaging with CfQVIP. When adopted, this FDA regulation will be based on the FDA’s experience with the Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the coronavirus disease 2019 (Covid-19) public health emergency | 04 May 2022

The FDA issued a guidance document to give the policy to help address existing manufacturing limits or supply chain concerns due to the public health emergency created by COVID-19.

BAHRAIN

Assigning a Post marker surveillance officer | 12 May 2022

As part of the NHRA’s role in ensuring the safety of medical devices in the post-market phase, all healthcare facilities and authorised representatives are strongly encouraged to appoint a PMS officer who is responsible for medical device reporting in the post-market surveillance stage, including field safety notices, adverse events, and complaint reporting to the NHRA.

INDIA

Insertion of rule 43A in MDR 2017 for suspension and cancellation of license | 18 May 2022

The Ministry of Health and Family Welfare has released a Notification to the Official Gazette to amend the Medical Devices Rules 2017. Following consultation with the Drugs Technical Advisory Board and in the exercise of the powers provided by sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the Central Government applies the following regulations to modify the Medical Devices Rules, 2017:

  • These rules may be called the Medical Devices (Third Amendment) Rules, 2022
  • They will take effect on the day they are published in the Official Gazette.
  • Rule 43A – Suspension and cancellation of license for the entity failing to comply with the conditions of an Import License

PAKISTAN

Amendments in the Medical Devices Rules, 2017| 18 May 2022

On 27 April 2022, the Drug Regulatory Authority of Pakistan (DRAP) received approval from the Federal Government to amend the Medical Devices Rules, 2017. The document can be found here.

April Newsletter

AUSTRALIA

Transitioning to the new Therapeutic Goods Advertising Code | 05 April 2022

The Therapeutic Goods Administration (TGA) is updating advertisers on the transitional arrangements for the 2021 Advertising Code, particularly regarding hard copy ad stock.

On January 1, 2022, the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Code) went into effect. The Therapeutic Goods Advertising Code (No. 2) 2018 is repealed and replaced by the 2021 Code (2018 Code). Advertisers can comply with either the 2021 Code or the 2018 Code during the transition period, which runs through June 30, 2022.

In comparison to the 2018 Code, the mandatory statement requirements in the 2021 Code have been streamlined and decreased in number. However, the TGA recognises that advertisers may have hard copy advertisements on hand that meet the 2018 Code’s statutory statement requirements but are not strictly compliant with the 2021 Code. While marketers use up their existing hard copy inventory, the TGA will take a pragmatic approach and refrain from taking enforcement action when advertisers follow the 2018 Code’s mandatory statement requirements rather than the 2021 Code’s. The TGA expects marketers to move to the 2021 Code requirements by the end of the transition period on 30 June 2022 for advertising that can be easily altered.

UNITED STATES OF AMERICA (USA)

Counterfeit At-Home OTC COVID-19 Diagnostic Tests | 29 April 2022

Counterfeit COVID-19 tests are tests that have not been authorised, cleared, or approved by the FDA for distribution or use in the United States but are designed to appear like authorised tests so that consumers believe they are actual FDA-approved tests. The FDA is worried about the possibility of erroneous findings when consumers use these illegal tests since the performance of these bogus tests has not been thoroughly proven. The FDA has a list of authorized at-home OTC COVID-19 diagnostic tests.

Resilient Supply Chain Program for Medical Devices| 20 April 2022

The Resilient Supply Chain Program (RSCP) for medical devices aims to strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to minimise medical device shortages.

The RSCP was created to improve the FDA’s ability to prevent and mitigate supply chain disruptions and promote resiliency in the US medical device supply chain to ensure that patients have access to safe and effective medical devices by: 

  • Developing strategies, analyses, and informational products to prevent and, when appropriate, mitigate medical device supply chain disruptions and shortages
  • Identifying supply chain hazards and disseminating actionable information to medical device manufacturers, distributors, healthcare delivery organisations, patients, healthcare employees, and government partners. Developing communication channels across the medical device ecosystem to enhance collaborations for the development of prevention and risk reduction strategies 
  • Enhancing collaborations for the development of prevention and risk reduction strategies by developing communication channels across the medical device ecosystem 
  • Working with government partners and medical device stakeholders to evaluate supply chain disruption and shortage signals, assess potential consequences, and provide public health data to assist an informed response.

Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication | 19 April 2022

The Food and Drug Administration (FDA) in the United States is alerting consumers and healthcare providers about the dangers of misleading results from genetic non-invasive prenatal screening (NIPS) tests, also known as non-invasive prenatal testing or tests (NIPT). NIPS tests can reveal whether a foetus has specific genetic abnormalities that could lead to a child being born with a severe health problem.

The FDA is providing this information to educate patients and health care providers and assist limit the improper use of NIPS testing due to the increased usage of these tests and concerns raised in recent media stories. Before electing to receive NIPS tests, the FDA suggests that patients talk to a genetic counsellor or other health care provider about the benefits and dangers. Before making any decisions concerning their pregnancy, patients should review the results of NIPS tests with a genetic counsellor or other health care practitioner. These screening tests have dangers and limits, and the results should not be used to identify chromosomal (congenital) abnormalities or illnesses on their own.

Breakthrough Devices Program | 15 April 2022

The Breakthrough Devices Program is a voluntary programme that recognises specific medical devices and device-led combination solutions that improve the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The FDA’s Breakthrough Devices Program allows manufacturers to interact with FDA experts through various programme options, allowing them to address issues that arise during the premarket review phase quickly. This programme can help manufacturers receive feedback from the FDA and identify areas of agreement. Manufacturers might also expect their submission to be reviewed first.

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | 07 April 2022

FDA Released draft guidance that applies to devices that incorporate software (including firmware) or programmable circuitry, as well as software as a medical device (SaMD). The guidance is not restricted to network-enabled devices or have other linked features. The guidance offers suggestions for cybersecurity information to be supplied for devices under the following premarket submission categories:

  • Premarket Notification (510(k)) submissions
  • De Novo requests
  • Premarket Approval Applications (PMAs) and PMA supplements
  • Product Development Protocols (PDPs)
  • Investigational Device Exemption (IDE) submissions
  • Humanitarian Device Exemption (HDE) submissions

The document can be found here.

Medical Device Interoperability | 05 April 2022

Medical device interoperability refers to the capacity to share and use data between one or more devices, products, technologies, or systems in a safe, secure, and efficient manner. This data can be displayed, stored, interpreted, analysed, and utilised to automatically act on or control another product, among other things.

As electronic medical devices grow more connected to one another and other technologies, the capacity of interconnected systems to share and use data safely, securely, and effectively becomes increasingly essential.

Interoperable devices that can communicate data across systems and platforms can help to improve patient care, reduce errors and adverse events, promote innovation, and enable more diversified study datasets.

The FDA encourages intelligent, secure, and safe interoperability between medical devices and information systems. To promote medical device interoperability, the agency has worked with hospitals, health care providers, manufacturers, standards development organisations, and other interested parties. 

EUROPEAN UNION (EU)

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | 26 April 2022

The difference between Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC on medicinal goods for human use (MPD) is critical for the appropriate implementation, interpretation, and enforcement of the two sets of laws.

Several sections in the MDR and MPD serve as a separating line between the two legal frameworks. This guidance document includes further clarifications and examples of essential regulations to aid in the uniform implementation of the MDR across the EU. A working group of experts from Member States’ relevant agencies, Commission services, the European Medicines Agency, and various stakeholders prepared the document.

Clinical Trials Regulation Question and Answer document | 13 April 2022

European Commission has released a question-and-answer document on Clinical Trials Regulation (EU) 536/2014. The goal of the paper is to provide answers to clinical trial-related issues. This article contains commonly requested ‘questions and answers about how the rules on clinical trials are implemented. All revisions to these questions and answers are given and debated by the “Expert group on clinical trials” and reflect the group’s viewpoint. The document can be accessed here.

EUDAMED – UDI/Devices technical documentation update | 11 April 2022

Regulations (EU) 2017/745 and 2017/746 introduced the EU device identification system based on a unique device identifier (UDI), allowing medical devices traceability. This requires that manufacturers submit the UDI/Device information of all devices they place on the EU market in EUDAMED. The document clarifies the data provided in EUDAMED for the UDI module.

EUDAMED – NBs & Certificates module technical documentation update | 11 April 2022

Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn, or refused and other restrictions imposed on these certificates. Such information is accessible to the public. The document clarifies the update in the EUDAMED NB & certificates module.

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 01 April 2022

The IVDR (In-Vitro Diagnostic Medical Devices Regulations) is set to effect on 26 May 2022. The Medical Device Coordination Group (MDCG), which comprises experts appointed by the Member States, approved a Joint Implementation Plan for the MDR in March 2020. Priority activities for Member States and Commission services were outlined in the plan, which would be monitored at the MDCG level. The MDR joint implementation plan acknowledged a similar process for the IVDR. As a result, the present document proposes a draft IVDR joint implementation plan. The document was updated this month.

ITALY

Report on surveillance activities 2020 | 08 April 2022

The report outlines the medical device and in vitro diagnostic medical device monitoring operations carried out during 2020. The report analyses the data collected in the Ministry’s supervisory system database based on health professionals’ and manufacturers’ recommendations. The publication is aimed at all stakeholders in the device sector, including manufacturers, healthcare professionals, patient associations, and central and local institutions interested in purchasing and managing medical devices and in vitro medical-diagnostic devices. It allows the reader to acquire helpful information elements to carry out better their professional activity in medical devices and in vitro medical-diagnostic devices that have already been placed on the market. The Italian report can be found here.

IRELAND

Webinar – In-Vitro Diagnostic Medical Devices Regulation | 21 April 2022

The HPRA (Health Products Regulatory Authority) will host a free webinar on the In-Vitro Diagnostic Medical Devices Regulation (IVDR), which will address significant subjects and provide practical information on the IVDR’s implementation, regulatory implementation at the national and European levels, post-market surveillance, vigilance and registration requirements, and HPRA inspections and performance studies. For registration, visit here.

Annual Communication | 21 April 2022

If the synthetic methods, processing equipment, cleaning or containment procedures are comparable to active substances, HPRA has published a form for the manufacturer, importer, or distributor of active substances to add new active substances to the registration.

Medical Device Regulation: Survey for healthcare professionals | 25 April 2022

The Health Products Regulatory Authority (HPRA) is surveying to assess healthcare professionals’ awareness and understanding of medical device (MD) and in vitro diagnostic medical device (IVD) laws in Ireland. This survey’s results will only be used to identify particular regulatory subjects of concern to healthcare professionals and determine how to effectively help them with medical devices and IVD regulations. The survey can be found here, and the deadline to submit it is 13 May 2022.

MALTA

Self-Test COVID-19 Kits | 15 April 2022

The Malta Medicines Authority has released applications inviting distributors to submit applications to make Covid-19 Self-Test Kits available to the public.

POLAND

Introduction of robotic surgery to the public health system | 08 April 2022

Health Minister Adam Niedzielski launched the introduction of robotic surgery into Poland’s public healthcare system.  The financing of robotic surgery procedures is a technological leap in Polish healthcare; all operations will be reimbursed according to a specially calculated tariff, said Adam Niedzielski at the Provincial Specialist Hospital in Wrocław during a conference on the development and financing of robotics inpatient treatment. – On the one hand, robots make doctors’ jobs simpler, and on the other hand, it ensures that patients receive the best possible care’ he added further.

UNITED KINGDOM (UK)

Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain | 04 April 2022

The United Kingdom is designated as a Third Country to export Active Substances for Human Use to the European Economic Area (EEA). Northern Ireland’s active substance manufacturers will continue to be accepted by the European Economic Area. Each shipment of Active Substance manufactured in the UK exported to the EEA, and Northern Ireland will then require a Written Confirmation. For the Written Confirmation, a template has been created here. This Written Confirmation certifies the following for a third nation exporting Active Substances to the EEA:

  • the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA
  • the manufacturing plant is subject to regular inspections (which may be both announced and unannounced)
  • significant non-compliance events would be communicated to the EEA without delay

BRAZIL

Import of goods and products under sanitary surveillance | 20 April 2022

ANVISA issued a Notice inviting any individual or institution interested in the topic to provide data and information to identify difficulties encountered in the import procedures of goods and products subject to sanitary monitoring. The implementation of laws for international trade activities should consider the promotion of product access and the reduction of the health risk of these items to the Brazilian population. Any person or organisation interested in the issue is welcome to participate in the consultation, particularly those involved in foreign commerce, such as importers, exporters, customs brokers, carriers, customs, and representatives from other federal agencies. Those interested in taking part must complete the survey between 26 April 2022 and 09 June 2022.

ANVISA discloses data on adverse events | 07 April 2022

The 1st Newsletter on Post-Market Monitoring of products and services subject to health surveillance has been released by ANVISA. Based on data from the System of Notification and Investigation in Sanitary Surveillance, the publication includes information on notifications of adverse events, technical complaints, product quality deviations, and reports of intoxications. The data covers poisoning, Surveillance and Control Measures, Cannabidiol, Kit Intubation, Sanitizing, and Cosmetovigilance.

Implantable defibrillators and cardiac valve prostheses | 01 April 2022

ANVISA issued Call Notices 5 and 6 in the Official Gazette (D.O.U.) requesting holders of registrations for implanted defibrillators and cardiac valve prosthesis, which follow the technical qualities specified in Normative Instruction (IN) 119/2022 and having the following technical names:

  • Implantable double chamber defibrillator
  • Single-chamber implantable defibrillator
  • Implantable defibrillator for cardiac resynchronization therapy
  • Biological cardiac valve prosthesis
  • Mechanical cardiac valve prosthesis

to send technical attributes of each model of medical device (health product) registered with ANVISA for economic monitoring purposes in a spreadsheet. The technical attribute data collected will be used to create economic monitoring panels for implantable defibrillators and cardiac valve prostheses, which will enable the grouping of products with similar technical specifications and the disclosure of price history statistics used in public purchases, reducing asymmetric information in the market.

OMAN

MOH Gains ISO International Recognition | 13 April 2022

The Ministry of Health, represented by the Directorate General of Quality Assurance Center (DGQAC), was awarded ISO 9001/ 2015 certification by the International Organization for Standardization in 2020 for the following directorates:

  • The Directorate General of Administrative Affairs
  • The Directorate General of Financial Affairs
  • The Directorate General of Pharmaceutical Affairs & Drug Control
  • The Directorate General of Private Health Institutions
  • The Directorate General of Projects & Engineering Affairs

SINGAPORE

Guidance on Change Notification for Registered Medical Devices | April 2022

This guideline document aims to assist registrants in assessing whether a Change Notification for a medical device listed on the Singapore Medical Device Register (SMDR) is required. Registrants must inform the Authority about the modifications of the registered medical devices under the Health Products (Medical Devices) Regulations 2010 (Regulations). As a consequence of a reportable Adverse Event (AE) or an ongoing Field Safety Corrective Action, this guidance also applies to circumstances where a registered device undergoes any adjustments or planned changes, including labelling changes (FSCA). The guidance document can be accessed here.

Software Medical Devices – A Life Cycle Approach | April 2022

This guideline is produced by the Health Sciences Authority (HSA) to clarify the regulatory obligations for software medical devices across their entire life cycle, from product development through post-market activities following their launch in Singapore. This guideline is only a recommendation. It should not be interpreted as a new regulatory control on software medical devices by anyone involved in developing and providing such devices in Singapore. This paper addresses essential software-related regulatory requirements, such as cybersecurity and regulations for Artificial Intelligence (AI) medical devices, and it applies to the software of all Risk Classifications. With new software-related technologies and growing hazards, these rules will be evaluated and updated regularly. The document can be found here.

Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) | April 2022

To establish the risk categorization of Standalone Medical Mobile Applications that are Medical Devices, this guideline refers to the IMDRF’s Framework for Software as a Medical Device (SaMD) (commonly referred to as SaMD). This guideline further clarifies whether Clinical Decision Support Software (CDSS) is classified as a regulated medical device or not and the current regulatory approach and standards for such software regulated by HSA. The guideline can be found here.

HSA’s advisory on factors that may affect the accuracy of COVID-19 antigen rapid self-test kit results | 04 April 2022

COVID-19 testing, including polymerase chain reaction (PCR) testing and antigen rapid tests (ART), are helpful tools for detecting COVID-19 infection. While professional PCR tests and ARTs performed by healthcare professionals are assumed to have greater precision, self-testing remains an essential tool in public health response during a pandemic because it is easily accessible, inexpensive, and provides faster results in the detection of COVID-19. The Health Sciences Authority (HSA) has evaluated all COVID-19 ART self-test kits to fulfil the required safety, performance, and quality requirements. However, the test findings may be influenced by a variety of circumstances, including the viral load of the individual and the sampling method used. Companies must notify HSA of any erroneous findings from their ARTs that they are aware of, and HSA must investigate to rule out any quality or performance concerns with their tests. HSA is actively watching local and worldwide trends and will take appropriate measures if necessary.

Guidance – Special Access Routes (SAR) | 01 April 2022

All Class B, C, and D medical devices must be registered with the Health Products Act (Act) and the Health Products (Medical Devices) Regulations 2010 (Regulations) before being sold in Singapore. Qualified practitioners (i.e., physicians and dentists) sometimes need access to unregistered medical devices to fulfil exceptional clinical needs emerging in their profession in an emergency or when all conventional treatments have failed. Qualified practitioners may use unique access methods to access unregistered medical devices for use on their patients. More details can be found here.

Note: The Special Access Routes (SAR) updates for unregistered medical devices will take effect from 1 April 2022.

Webinar – Dental Laboratory Regulatory Requirements in Singapore | 01 April 2022

The Singapore Health Sciences Authority will have a Zoom webinar to discuss the regulatory standards for dental laboratories that manufacture or modify dental devices. The regulatory obligations that apply to dental laboratories that manufacture devices for local use and guidance on the notification and reporting processes will be covered in this webinar. For more details and registration, visit.

PAKISTAN

DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country | 27 April 2022

DRAP has regulatory control over the import and export of all therapeutic products to evaluate if they are permissible under relevant drug laws and prohibits entrance or exit of any therapeutic commodity if the regulatory standards are not met. These regulatory measures are in place to prevent substandard therapeutic products from entering the market and to ensure that standard quality therapeutic goods are available. These regulatory controls are in place to keep inferior products out of the supply chain and ensure that standard quality therapeutic commodities are available. The document can be accessed here.

March Newsletter

AUSTRALIA

Consumer/Patient information materials requirements | 02 March 2022

On 26 October 2017, the Australian government passed laws requiring implanted and active implantable medical devices to include patient information materials (patient information booklets and patient implant cards). More flexibility in information delivery was introduced by providing electronic formats. Manufacturers of all implanted devices in the ARTG (Australian Register of Therapeutic Goods), excluding those exempts, have been required to provide patient education materials since 1 December 2021. To be regarded as compliant, patient education materials must follow the Essential Principles; else, the sponsors must ask for permission who want to import, supply, or export medical devices that don’t follow the Essential Principles.

UNITED STATES OF AMERICA (USA)

Mitigating and preventing medical device shortages | 17 March 2022

There have been shortages of different medical devices throughout the epidemic that are vital to public health and safety. To deal with these shortages, the FDA’s Center for Devices and Radiological Health (CDRH) obtained additional statutory power in 2020, according to the CARES Act, to reduce and avoid device shortages during or after a public health emergency. The CARES Act mandated certain medical device makers to report product availability and any significant supply chain interruptions to the FDA. CDRH has improved its understanding and monitoring of the intricate web of supply chains that feed the medical device sector, allowing it to be more proactive in preventing issues. The CARES Act’s authorities have resulted in a very productive partnership between CDRH, manufacturers, and other partners to address supply chain risks. For example, the FDA collaborated with manufacturers to plan for faster marketing applications and increase device availability for COVID-19-related products, such as vaccination administration.

Voluntary eSTAR Program | 11 March 2022

eSTAR is a free interactive PDF form that assists submitters of 510(k)s and De Novos in preparing a detailed medical device submission. The form contains:

  • Automation (for example, form construction and autofill)
  • Content and structure that is complementary to Center for Devices and Radiological Health (CDRH) internal review templates
  • Integration of multiple resources (for example, guidances and databases)
  • Guided construction for each submission section
  • Automatic verification

eSTAR programme aims to improve the quality of medical device submissions by assisting submitters in providing excellent, detailed information for the CDRH’s premarket evaluation. The CDRH does not intend to perform a Refuse to Accept (RTA) evaluation for eSTAR submissions due to automated verification.

CANADA

Legislation to increase access to rapid testing across the country receives Royal Assent | 04 March 2022

Bill C-10 – An Act respecting certain measures related to COVID-19 gave Health Canada $2.5 billion in financing and the legal ability to buy and deploy COVID-19 fast testing across the country. With this money, the federal government will ship millions of COVID-19 rapid tests to provinces, territories, and indigenous communities for free during the next three months. The financing also permits Health Canada to continue distributing tests through partners such as the Canadian Red Cross, chambers of commerce, and pharmacies. The Royal Assent of Bill C-10 ensures that everyone in Canada has greater and equal access to fast testing.

Clinical trials for medical devices and drugs relating to COVID-19 regulations | 02 March 2022

These regulations came into effect on 27 February 2022 and were published on 02 March 2022 as a replacement for Interim Order No. 2, which will be expiring on 03 May 2022. The flexibility granted by the interim order is maintained by these Regulations until the framework created by the Clinical Trials Modernization Initiative is in place. The regulations will:

  • Minimize the administrative load
  • Maintain the health and safety criteria for trial participants ensuring the authenticity of trial data
  • Ease to obtain and carry out COVID-19-related clinical studies

BRAZIL

ANVISA reviews and consolidates standards in the Cosmetics and Sanitizing areas | 18 March 2022

On 16 March 2022, ANVISA published new regulations in the Official Gazette of the Union, which review and consolidate standards in the areas of Cosmetics and Sanitising. The regulations will take effect on 01 April 2022 with the aim of removing ambiguity, upgrading the terminology and language of the current legislation, and replacing acts that have lost their significance.

In-Cosmetics, the following RDCs were published:

  • RDC 628/2022: improvement of the legislative technique of RDC 44/2012, which provides the list of dyes allowed for personal care products, cosmetics and perfumes and internalises the GMC Resolution Mercosul 16/2012. 
  • RDC 629/2022: improvement of the legislative technique of RDC 30/2012, which provides sunscreens and multifunctional products in cosmetics and internalises the GMC Resolution Mercosul 08/2011.  
  • RDC 630/2022: improvement of the legislative technique of Resolution 481/1999, which stabs parameters for microbiological control of toiletries, cosmetics and perfumes and internalises GMC Resolution Mercosul 51/1998.

In Sanitizing, the following RDCs were published:

  • RDC 622/2022: improvement of the legislative technique of RDC 52/2009, which provides for the operation of companies specialised in the provision of vector and urban pest control services. 
  • IN 121/2022: improvement of the legislative technique of IN 4/2012, which provides the acceptance criteria of test reports required for analysis of requests for notification and registration of sanitising products.

ANVISA’s approval for self-tests for Covid-19 | 17 March 2022

For the registration of self-testing products on ANVISA, the products are evaluated for safety, performance and compliance with the legal requirements required for tests. Usability of guidelines of the products should be in such a way that the instructions in simple plain language would guide the layperson to use the product correctly.

ANVISA changes electronic import licensing petitioning | 11 March 2022

From 19 March 2022, the subjects available in the contingency plan for the Import Licensing petition will be unavailable. Users will still be able to file secondary petitions for processes that have already started, such as compliance with requirements, amendments, administrative appeals, etc. The petitions for all matters of consent for Import Licensing carried out by companies will no longer be made by the Electronic Import Petition (PEI) system in six stages, to be completed by 31 August 2022. To obtain import approval, stakeholders must first register their requests in the Single Foreign Trade Portal’s Licenses, Permissions, Certificates, and Other Documents (LPCO) module, then follow the procedure in the Solicita System.

ANVISA publishes standard and manual on compassionate use of medical devices| 04 March 2022

The Resolution of the Collegiate Board of Directors (RDC) 608/2022, which deals with the compassionate use of medical devices, was published in the Official Gazette (DOU). The standard governs programmes aimed at assisting patients with a serious disease for which there is no sufficient therapeutic solution in the country. Companies want to offer a medical device that is still in the validation phase and has a favourable benefit-risk ratio to the patient. This still-under-development process for gaining access to medical devices exists in numerous countries. It allows individuals who might benefit from innovative technologies to receive access to these devices that rely on manufacturer initiative and appropriate health control so that the patient may be observed while safely using the device. It’s crucial to note that it is not a clinical study since the information gathered from patients using medical devices in “compassionate use” does not assist the registration of new products but may use in the medical device’s design and clinical assessment.

EUROPE

Update of MDCG 2019-9 Rev.1 Summary of safety and clinical performance | 24 March 2022

As per the Medical Device Regulation (MDR 2017/745), for implanted devices and class III devices other than custom-made or experimental devices, it is mandatory for the manufacturer to prepare a summary of safety and clinical performance (SSCP). A notified body (NB) must validate the SSCP before it may be made public via the European database on medical devices (EUDAMED) to provide an updated summary of the clinical performance and safety of a medical device and improve transparency.

AUSTRIA

Certified SARS-CoV-2 antigen rapid tests | 25 March 2022

A list of Certified self-testing SARS-CoV-2 antigen rapid tests is provided on the Austrian BASG website. A notified body has been involved as an independent conformity assessment body to examine the eligibility of these tests, and a 4-digit number is affixed next to the CE Mark. Manufacturers of approved self-testing kits who sell their products in Austria are required to provide the following information to be on this list:

  • Trade name of the SARS-CoV-2 rapid antigen test
  • Address and name of the manufacturer
  • Address and name of the authorized representative
  • Declaration of conformity and certificate of the notified body
  • Type of sample collection

Clinical investigations with medical devices | 07 March 2022

The Federal Office for Safety in Healthcare published two guidance’s in German pursuant to Regulation (EU) 2017/745 for initial applications and modifications.

IRELAND

European Commission launches public consultation on the targeted revision of the Cosmetic Product Regulation | 30 March 2022

The European Commission has started an online public consultation until 20 June 2022, to gather comments from all relevant stakeholders on the planned amendment of the Cosmetic Product Regulation 1223/2009. The project focuses on various activities and prospective initiatives to improve the efficiency and efficacy of present cosmetic product regulations.

SWITZERLAND

Direct procurement of foreign medical devices by healthcare professionals in Switzerland | 17 March 2022

The Medical Devices Ordinance allows professionals to procure devices directly from foreign lands for use without putting them on the market, with individual professionals and health institutions automatically assuming full functional responsibility, i.e., no Swiss economic operator is responsible for any procedural or safety-related issues, and delivery readiness is solely dependent on the foreign supplier. This guidance document outlines such professional procurement, what responsibilities the personnel must undertake, and how they may outsource procurement duties. There is also information on the potential implications on supply continuity and the potential consequences of non-compliance with legal standards. The document can be accessed here.

Update of the information sheet – Unique identification number (CHRN – Swiss Single Registration Number) | 03 March 2022

The CHRN is a unique identifying number that may be used to identify a Swiss manufacturer, authorised representative, or importer. Swissmedic does not grant CHRNs to companies based outside of Switzerland. This version 2 of the information sheet reflects the amendments in the structure, new essential material insertion, and the document’s renaming.

In-vitro Diagnostic Ordinance Timeline | 22 February 2022

The Swiss authorities proposed the crucial deadlines related to Swiss IvDO.

CZECH REPUBLIC

Notice to exemption holders for antigen tests to diagnose Covid-19 | 03 March 2022

Antigen tests for Covid-19 that were granted a self-testing exemption by the Czech Republic’s Ministry of Health with effect until 30 June 2021, under the provisions of Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices, can no longer be placed on the market. These tests can be purchased until that date, and their usage is governed by the expiration date printed on the product. If entities want to continue market tests, it is necessary to repeatedly ask the Ministry of Health for an exemption. Suppose an exemption is granted multiple times to an antigen test that has already been notified to the Register of Medical Devices. In that case, the economic operator must submit an application for a change of the medical device, in which he must enter the file number of the newly issued exemption decision in the certificate number field and upload the decision in question to the annex. If the economic operator no longer applies for an exemption, the medical device must be removed from the RZPRO once the exemption has expired. The Institute will remove the medical device from the RZPRO if they do not respond within 30 days of the exemption expiring.

ITALY

Publication of the MDCG guideline 2022-4| 21 March 2022

The document informs notified bodies about the proper procedures for conducting surveillance operations on CE-marked devices in compliance with the Directives, regardless of whether those notified bodies have applied for designation or are designated under the MDR, as long as the relevant authority responsible for notified bodies has the right to and does monitor the notified body’s activities.

Information on procedures for placing surgical masks on the market | 10 March 2022

Manufacturers who wish to keep surgical masks on the market in Italy after 1 April 2022 will have to follow standard medical device regulations. The circular dated 4 March 2022 specifies that masks approved by the exemption that have already been placed on the market can only be accessible until 31 May 2022. It is emphasised in the circular that it will no longer be possible to place CE marked surgical masks which followed Directive 93/42/EEC, on the market after 26 May 2021. The manufacturers who intend to place surgical masks on the market must comply with the Medical Devices Regulation requirements (EU MDR) 2017/745. As per the regulation, the manufacturer must:

  • Prepare the technical documentation complying with the general performance and safety requirements set out in Annex I of the Regulation
  • Present the documents in a clear, structured, straightforward, and easily available manner
  • Include the test methods and results supporting compliance with the specifications
  • Provide tests of bacterial filtration efficiency, respirability, microbial contamination, splash resistance (only in the cases provided, IIR type masks) and biocompatibility
  • Maintain, update and constantly improve the quality management system
  • Register in the European Database of Medical Devices (EUDAMED) once fully operational
  • Establish and update a post-market surveillance system
  • Declare the conformity of their products by drawing up the EU declaration of conformity referred to in Article 19 of the Regulation and affix the CE marking following Annex V

RUSSIA

The electronic form for submitting information | 25 March 2022

The Federal Service of the Russian Federation informed about an application form on the website for the manufacturers, Authorized Representative or a person importing Medical Devices into the Territory of the Russian Federation to submit the information as per the order number 11020 of Roszdravnadzor posted on 25 November 2021.

TANZANIA

Fees and charges regulations, 2021 | 15 March 2022

Tanzania Medicines and Medical Devices Authority (TMDA) has approved the new Regulations for Fees and Charges, 2021, effective from 01 April 2022. The relevant fees for all the services should be transferred through the Government electronic payment system (GePG) after obtaining a Pro-forma invoice from TMDA indicating a payment Control Number.

BAHRAIN

Medical Devices Shelf-Life Guideline | March 2022

National Health Regulatory Authority (NHRA) published a guideline regarding the service life of medical devices. Below aspects are discussed in the guide:

  • Factors influencing shelf-life
  • Variables like storage conditions, transportation, packaging, sterilization, etc.
  • Contents of shelf-life to be included by the manufacturers

Note for all the importers and shop owners of lenses | 03 February 2022

With regards to the medical devices regulations, National Health Regulatory Authority (NHRA) informs all importers and shop owners of medical and cosmetic lenses to verify the lenses and get approval from NHRA, ensuring the quality and safety of health services.

Medical Device Management Guideline | February 2022

National Health Regulatory Authority (NHRA) designed the guidance to assist all NHRA-licensed healthcare institutions in managing Medical Devices throughout their life cycle, including procuring, installing, maintaining, calibrating, and decommissioning.

Medical Devices Labelling Guideline| February 2022

To guide all importers, healthcare facilities and users of medical devices, NHRA published the guideline to realize the importance of labelling medical devices. Labels ensure that the medical devices are used by the end-users as per the devices’ intended use and manufacturer’s instructions, and not another way around. Labellings inform about the:

  • Risks and advantages of the equipment in user-friendly language
  • Proper use and operation of the device with the help of adequate directions.
  • Recognize, store, assemble, and troubleshoot

INDIA

List of Notified Bodies registered with CDSCO under MDR 2017 | 11 March 2022

With the publishment of the Medical Device Regulation under the Drugs and Cosmetic Act for regulating the manufacture, import, sale, and distribution of medical devices, a list of notified bodies registered with the CDSCO to carry out the audits is provided.

PAKISTAN

Notification of Amendments in Form 6A and Form 7A | 29 March 2022

Drug Regulatory Authority of Pakistan (DRAP) notified about the amendments made in the Form 6A and Form 7A of the Medical Devices Rules, 2017. The forms can be accessed here.

February Newsletter

EU REGULATIONS

MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022

Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state[A1] s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR and no later than 26 May 2024 under certain conditions. The mentioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance with respect to all the applicable requirements relating to the devices it has certified. Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3) of the MDR.

MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies | 15 February 2022

Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices [A2] (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes IVDs. Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis.

This document aims to provide guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of the IVDR. This guidance also describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs. It also includes guidance on:

  • relevant information to be included within the notified body’s procedures,
  • the content of the required pre-agreed conditions and detailed arrangements between the notified body and the manufacturer,
  • guidance on the frequency of samples of devices or batches of devices to be sent to the EURL.

Update – MDCG 2021-21 Rev.1 – Guidance on performance evaluation of SARS-CoV-2 In Vitro Diagnostic Medical Devices | 15 February 2022

The guidance document concerns performance evaluation of SARS-CoV-2 In Vitro Diagnostic Medical Devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens, and detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs. The guidance is addressed to all interested parties, including the manufacturers, as well as notified bodies and competent authorities, authorised representatives, other market operators, professional and patient associations. The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.

Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR | 07 February 2022

A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. The MDR was envisaged to apply from 26 May 2020. In contrast, the IVDR has a date of application of 26 May 2022. In March 2020, the Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR. The plan listed priority actions for the Member States and Commission services, to be monitored at the level of the MDCG. The MDR joint implementation plan recognised the need to carry out a similar exercise for the IVDR. The present document therefore proposes a draft joint implementation plan for the IVDR.

IRELAND

Guide to Classification of a Medical Device | 16 February 2022

This document is a guide for classifying medical devices covered by the European Directive 93/42/EEC, as amended and the related Irish regulation, S.I. No. 252 of 1994, (‘the Regulation’). It outlines the process for classifying medical devices and explains how to seek clarification on classification of a medical device. This guide sets out, inter alia, the reasons for classification and the routes to correctly qualify or classify a product under the Medical Device Regulation 2017/745 (MDR).

AUSTRIA

Clinical investigations with medical devices | 04 February 2022

As of 28 January 2022,[A3]  a new fee regulation of the BASG was put into force. From this date new fees apply for:

  • clinical investigations of medical devices according to Regulation (EU) 2017/745
  • performance evaluation studies of in-vitro diagnostics according to Directive 98/79/EC and
  • amendments of clinical investigations of medical devices according to Directives 90/385/EEC and 93/42/EEC.

The electronic registration form is mandatory for a proper initial application for clinical testing of a medical device or performance assessment of an in vitro diagnostic medical device.

The following situations could potentially block [A4] the processing of an initial application or amendment and will result in an immediate e-mail response to the applicant that the procedure cannot be further processed:

  • Missing or corrupted BASG application form (PDF and XML[A5] )
  • No final positive ethics vote available for the overall study
  • Clinical investigation plan, investigator’s brochure or patient information(s) are missing or do not comply with the versions in the final ethics committee opinion

The applicant is then also granted a period of 10 days for correction or submission of documents. In justified cases an extension can be requested for up to 20 days.

ITALY

Expenses for promotional activities of medical devices | 24 February 2022

All companies that produce or market medical devices, must send the declaration relating to the total amount of expenditure incurred in the year 2021 to the Ministry of Health, for promotional activities by 30 April 2022. Information about the declaration and payment is available here.

In Vitro Diagnostic Medical Devices Regulation (EU) 2022/112 | 03 February 2022

The Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 in relation to the transitional provisions for certain medical-diagnostic devices has been published in the Official Journal of the European Union vitro and the deferred application of conditions concerning in-house manufactured devices.

With this document we are moving towards a progressive introduction of the Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices. Regulation (EU) 2022/112 does not modify the requirements of Regulation (EU) 2017/746 in substance, but modifies its transitional provisions (Article 110).

No changes are foreseen for CE marked devices that do not require the intervention of a notified body or for “new” devices, i.e., those which have neither a certificate from a notified body nor a declaration of conformity pursuant to current directive 98/79 / EC.

For these types of devices, Regulation (EU) 2017/746 will apply from May 26, 2022, as envisaged. There is also a delay in application of the requirements for in-house devices. Regulation (EU) 2017/746 introduced a set of common rules for such devices, which include requirements for the justification of their use and rules to ensure their safety and performance, such as an adequate quality management system.

CZECH REPUBLIC

Modification of the KZ module in RZPRO | 25 February 2022

The KZ module in Registry for Medical Devices (RZPRO) was modified so that in the case of submitting an application for permission to change KZRO and applications for the continuation of KZ, separate file marks were generated. Therefore, the mentioned proceedings will no longer be conducted under the file number that was assigned to the KZ permit application. In the field of clinical trials, it is necessary to distinguish between individual procedures and therefore a separate file must be kept for each. A manual of the changes can be found here.

BELGIUM

Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market | 24 February 2022

The European Regulation 536/2014 (Clinical Trial Regulation, CTR) came into force on 31 January 2022 and allows the packaging/labelling of investigational medicinal products already on the market not to be adapted for the clinical trial, except under special circumstances. 

LATVIA

Information about Clinical Trials Information System (CTIS) | 17 January 2022

Based on the new Clinical Trials Regulation, an informative presentation on Clinical Trials Information System (CTIS) has been prepared, and can be accessed here.

UNITED KINGDOM

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland | 07 February 2022

The guidance explains about obtaining a Written Confirmation for each shipment of Active Substances manufactured in Great Britain (England, Wales and Scotland) that is exported to the EEA or Northern Ireland. Importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation is accepted from the following list of countries:

  • European Economic Area (EEA) countries
  • USA
  • Japan
  • Republic of Korea
  • Brazil
  • Australia
  • Israel
  • Switzerland
  • Northern Ireland

AUSTRALIA

Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia | 22 February 2022

The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. TGA released this Discussion Paper seeking feedback on potential changes to mandatory reporting of medical device adverse events – as part of the reform program.

The discussion paper can be found here.

Special Access Scheme (SAS)| 18 February 2022

The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient. Therapeutic goods that are not included in the ARTG (and are not otherwise exempt from being in the ARTG) are described as ‘unapproved’. SAS applications and notifications can only be submitted by certain registered health practitioners.

Notifying or submitting an application: SAS Online System

Consultation on potential regulatory options for ‘export only’ biologicals| 15 February 2022

The Therapeutic Goods Administration (TGA) conducted a public consultation on potential options for the regulation of biologicals manufactured in Australia for export only (and not for supply in Australia). Currently, biologicals included in the Australian Register of Therapeutic Goods (ARTG) can be exported, but they are not permitted to vary from the product supplied in Australia. This means that ‘export only’ biologicals cannot have different indications, release specifications, or labels to the product approved by the TGA, even if the importing country has assessed and approved the product independently.

  • Opening date: 15 November 2021
  • Closing date: 22 December 2021

Importing COVID-19 Rapid Antigen Tests (RATs) | 11 February 2022

Only the approved supplier (sponsor) or their agent, as entered on the Australia Register of Therapeutic Goods (ARTG), can import rapid antigen tests (RATs) into Australia for commercial supply. The RATs must be on the ARTG, under the name of the supplier, prior to importation. Any RATs imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import. Many therapeutic goods, including RATs, are available both in Australia and overseas. When a legitimate version of an overseas product is imported with the goal of being marketed in the Australian market, this is known as parallel import. These goods may be genuine and made by the firm listed on the packaging, but they are not the version of the product that has been assessed for the Australian market and entered into the ARTG. Parallel imports may or may not satisfy the same quality and safety criteria as Australian counterparts, and the TGA has not inspected them. Parallel imports are unapproved items that should not be imported for commercial purposes into Australia.

ACMD meeting statement, Meeting 65| 10 February 2022

The Therapeutic Goods Regulations of 1990 established the Advisory Council on Medical Devices (ACMD), which is a statutory advisory committee. The TGA’s decision-making and other regulatory processes are aided by the committee’s independent expert input on specific scientific and technical matters. Synthetic ligament applications for Achilles Tendon, Anterior Cruciate Ligament, and Rotator Cuff injuries, which were considered at ACMD 53, were withdrawn, and there were no other decisions made for these items. At the 65th ACMD meeting, whether the benefits outweighed the risks for the devices and whether adequate evidence had been provided to demonstrate safety and performance through compliance with the Essential Principles, the committee considered Personalised Medical Devices and the following devices for discussion:

  • an application for a bone and soft tissue filler that can be used with infections
  • an application for a revision knee replacement system.

USA

About Manufacturer and User facility Device Experience (MAUDE) | 18 February 2022

Manufacturer and User Facility Device Experience (MAUDE) database represents reports of adverse events involving medical devices. The searchable database data contains the Medical Device Report [A6] [A7] (MDR) data of last 10 years. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

The public may search the database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE data is current through the end of the previous month. The FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed due to technical [A8] or clerical difficulties.

Medical Device Reporting (MDR): How to Report Medical Device Problems | 18 February 2022

The FDA is extending the comment period  on the document published December 23, 2022 (86 FR 72969) by 30 days. Submit either electronic or written comments on the draft guidance by March 24, 2022.

On December 23, 2021, the FDA issued the draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. This draft guidance will be open for public comments at www.Regulations.gov under docket number FDA-2021-D-0980. The FDA developed this draft guidance document to assist industry and FDA staff in assessing the credibility of Computational Modelling and Simulation (CM&S) used in medical device regulatory submissions.

This draft guidance, when finalized, is intended to help improve the consistency and transparency of the review of CM&S evidence, to increase confidence in the use of this evidence in regulatory submissions, and to facilitate improved interpretation of this evidence submitted in regulatory submissions reviewed by FDA staff. This draft guidance is not for implementation.

Center for Devices and Radiological Health Appeals Processes | 17 February 2022

The Food and Drug Administration (FDA / Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with certain Center for Devices and Radiological Health (CDRH) appeals processes.

Establishment Registration and Device Listing for Manufacturers and Importers of Devices | 07 February 2022

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with establishment registration and device listing for manufacturers and importers of devices.

BRAZIL

ANVISA publishes standard on simplified analysis of clinical research | 23 February 2022

On 16 February 2022, in the Official Gazette (D.O.U), ANVISA published the Resolution of the Collegiate Board (RDC) 601/2022, which provides simplified analysis, on an exceptional and temporary basis, of clinical research petitions.  the standard deals with a regulatory measure to cope with an emergency, as provided for in item I, art. 39 of Ordinance 162/2021. The measure seeks to quickly release petitions for medical research, provided that these petitions have been authorized by regulatory authorities of remarkable recognition.

ANVISA approves the registration of the first self-test for Covid-19 in Brazil | 17 February 2022

To grant registration, ANVISA analyses several technical requirements, including usability and risk management, which serve to adapt the product to use by lay people, ensuring greater security. Guidelines on usage of the product can be found here.

ANVISA prohibits collection kit for testing and diagnosis of Covid-19 without registration | 16 February 2022

ANVISA clarifies that these products can only be marketed in the country after registration.

Regulating remote inspections| 14 February 2022

ANVISA published a document with questions and answers on the regulation of remote inspections of imported goods and products subject to sanitary surveillance in ports and airports in the country by the modality of the Integrated System of Foreign Trade (SISCOMEX). The objective is to allow the regulated sector to carry out inspections remotely on goods whose Import Licensing (IL) is under analysis by the Agency. According to the rules of Resolution of the Collegiate Board (DRC) 597/2022 published in the Official Gazette (D.O.U.), the standard will enter into force on 2 March 2022. 

CANADA

Publication of third Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers, and users | 21 February 2022

To accelerate access to certain medical equipment in Canada during the pandemic, Health Canada issued two interim rules on the importation and sale of medical devices for use in respect to COVID-19. On March 18, 2020, the first interim order was issued, and on March 18, 2020, the second interim order was issued. As Interim Order No. 2 was set to expire on 1 March 2022, Health Canada has put in place a third interim order. The first and second interim orders expedited the regulatory procedure for approving the importation or sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19 while ensuring that safety, efficacy, and quality requirements were satisfied. The goal of Interim Order No. 3 is to keep the same flexibility that Interim Order No. 2 provided. Unless otherwise specified, all application conditions remain the same as in the second interim order. As a result, all active authorizations and expanded use indications under Interim Order No. 2 will be continued under Interim Order No. 3. The manufacturer will not be obligated to take any action. Manufacturers of permitted devices under Interim Order No. 2 may continue to import and sell their products in Canada. Any terms and conditions imposed on an interim order authorisation issued under Interim Order No. 2 remain in effect. Manufacturers must continue to operate under the same conditions as before. Interim Order No. 3 will remain in place for up to 1 year.

Regulations to allow exceptional importation of medical devices to address shortages as of 2 March 2022 | 16 February 2022

Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021, come into force on March 2, 2022, which will allow the exceptional importation and sale of medical devices to help address shortages in Canada. Current provisions allowing the exceptional importation and sale of devices related to COVID-19 are set out under Interim Order No. 2 which will no longer be in effect after 1 March 2022. The amendments to the MDR allow medical devices that would not otherwise meet Canada’s regulatory requirements to be imported and sold. However, these devices must meet the following conditions:

  • the device is a substitute for one that is in shortage or at risk of being in shortage
  • the device is authorized for sale in another jurisdiction
  • the device is manufactured to quality standards comparable to those in the MDR
  • the importer has a medical device establishment licence (MDEL)
  • the importer informs Health Canada at least 5 business days before importing the device

SINGAPORE

Guidance on Medical Device Product Registration | 07 January 2022

The Health Sciences Authority (HSA) has amended the guidance document meant to assist applicants in the registration of medical devices under the Act and Regulations. This guidance document describes the procedures and general requirements for the submission of an application for a new Product Registration for medical devices. The document can be found here.

Guidance on Grouping of Medical Devices for Product Registration (Revision 2) | 07 January 2022

This version of GN-12 guidance document applies to all medical device registration applications submitted to HSA. The grouping criteria described in the GN-12-1 and GN-12-2 shall be strictly adhered to in submitting your medical devices for registration. This document is meant to provide guidance on the device specific criteria in determining whether certain models of specific medical devices can be included together and submitted in one product registration application.  Grouping of medical devices for product registration facilitates the inclusion of multiple devices in one application.

BAHRAIN

Medical devices registration fast-track communication and delivery of services | 06 February 2022

The National Health Regulatory Authority (NHRA) announced a partnership with Adliya Business Center CO. W.L.L (ABC) as a private agency for instant communication and delivery of services for medical device registration, to help applicants who are having trouble preparing the required documents, and to speed up the registration process. Applying through Adliya Business Center CO. W.L.L (ABC) is optional, as applicants can submit directly to NHRA.

Medical devices registration fast-track communication and delivery of services | 06 February 2022

In accordance with decision (48) of 2020 related to medical devices regulations, The National Health Regulatory Authority (NHRA) notified all the importers and shop owners, especially those who are selling medical and cosmetic lenses, about the necessity of verifying that the lenses are approved by NHRA.

Cases that will not be included in the medical device’s regulation | 06 February 2022

Based on the resolution no. (48) for the year of 2020, NHRA clarified that the following medical devices will not be subjected to registration:

  1. Medical device imported for healthcare facilities for:
  2. Emergency
  3. A single time and not planned to be imported on a regular basis 
  4. Medical devices imported for research and educational purposes
  5. Personal imported medical devices
  6. Custom-made medical devices or order for specific patient 
  7. Samples for exhibition and conferences

INDIA

Regulation of sale of medical devices via registration of premises under MDR, 2017 | 09 February 2022

A draft of certain rules further to amend Medical Device Rules 2017, published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. The draft rules can be accessed here, page 7.

January Newsletter

EU Regulations

MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 In vitro diagnostic medical devices | 12 January 2022

This notice is addressed to manufacturers of In-Vitro Diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection1 who are based in countries outside the EU or the EEA and who place or intend to place the abovementioned devices on the EU market. It is intended to highlight a number of common issues that EU national competent authorities have identified in the course of their market surveillance activities regarding the compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. These issues can also be relevant for SARS-CoV-2 devices which are transitioning to Regulation (EU) 2017/746.

Link : mdcg_2022-1_en.pdf

Presentations and recording- Webinar: “Regulatory possibilities to enhance cooperation among the EU’s government structures and complementarity within the EU acquis” | 11 January 2022

This webinar revolved around the EU regulatory possibilities in the field of health for developing an inclusive and equitable EU pharmaceutical strategy. Starting from the role of the European Commission, particularly of DG Santé in building cooperation among EU agencies (including the future HERA) and other parts of the European Commission more centrally in the EU’s governance structures, this webinar discussed the EU dynamics in approaching health and problematising health issues, notably in the context of the pandemic and vaccine strategy.

It also considered the question of the EU’s competence and its potential, be it with or without Treaty revision, both from an internal perspective within the EU, but also from an external/global perspective of how the EU can promote equitable access to pharmaceuticals in less economically developed countries outside the EU. A few specific examples of these regulatory challenges will be explored in more detail in order to evaluate the complementarity and interoperability of the EU’s legal framework (‘acquis’) on medicines with, for instance, the one applicable to patents, or the one applicable to genetically modified organisms.

Link: policy_20220111_hpp-news_en.pdf

Commission Implementing Regulation (EU) 2022/20 on setting up the rules and procedures for the cooperation of the member states in safety assessment of clinical trials | 10 January 2022

Commission Implementing Regulation (EU) 2022/20 on setting up the rules and procedures for the cooperation of the Member States in the safety assessment of clinical trials

Australia

Consultation: Fees and Charges Proposal 2022-23| 25 January 2022

The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2022-23 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed options, prior to seeking approval from the Government for any changes.

The TGA within the Department of Health is responsible for the supply, import, export, manufacturing and advertising of therapeutic goods. The TGA recovers its costs from the industry in accordance with the Australian Government Charging Framework. The Therapeutic Goods Act 1989 provides the legal authority for the TGA to charge for its regulatory activities. The Therapeutic Goods Act 1989  provides the legal authority to levy annual charges on sponsors and manufacturers of medicines, biologicals and medical devices.

COVID-19 rapid antigen tests – information for manufacturers and sponsors| 24 January 2022

All COVID-19 test kits must be approved for inclusion in the Australian Register of Therapeutic Goods (ARTG), in order to be legally supplied in Australia. One exception to this is for Class 4 in-house IVDs being used to perform donor screening under the emergency exemption.

All importers of COVID-19 test kits must apply for, and be granted, an import permit for all consignments of COVID-19 test kits that are imported into Australia, unless the importer can demonstrate that the goods are for personal use only or, for lateral flow test kits, meet the import conditions published on the Australian Biosecurity Import Conditions (BICON). The Department of Agriculture, Water and the Environment has published a new web page providing information about the import of COVID-19 Rapid Antigen Test Kits for both commercial and personal use.

To minimise price gouging and limit exportation of COVID-19 rapid antigen tests, an emergency determination(link is external) under section 477 of the Biosecurity Act 2015  was made. The determination also outlines the enforcement of price gouging and exceptions for exporting COVID-19 rapid antigen tests.

Advisory Committee on Medical Device (ACMD)| 19 January 2022

The Advisory Committee on Medical Devices (ACMD) provides independent medical and scientific advice to the Minister for Health and the Therapeutic Goods Administration (TGA) on the safety, performance and manufacturing of medical devices supplied in Australia including issues relating to pre-market conformity assessment and post-market monitoring.

The Committee is established under Regulation 38 of the Therapeutic Goods Regulations 1990. Members are appointed by the Minister. Membership is comprised of professionals with specific scientific, medical, and clinical expertise as well as appropriate consumer health issues relating to medical devices.

On 1 January 2017, functions of the Advisory Committee on the Safety of Medical Devices (ACSMD) were consolidated into ACMD to encompass pre and post-market advice for medical devices.

Limitations of pulse oximeters and the effect of skin pigmentation| 07 January 2022

COVID-19 has caused an increase in pulse oximeters being used to help estimate blood oxygen levels and therefore assist in monitoring a person with COVID-19 infection. Recent reports have highlighted that multiple factors, including skin pigmentation, can impact the accuracy of pulse oximeters. Overreliance on pulse oximeters could lead to suboptimal management of patients whose oxygen levels are below normal. This risk is higher in persons with darker skin.

USA

Assessing the credibility of Computational Modelling and Simulation in Medical Device Submissions- Draft Guidance for Industry and Food and Drug Administration Staff| 27 January 2022

This draft guidance document provides the FDA’s recommendations on a risk-based framework that can be used in the credibility assessment of computational modelling and simulation (CM&S) used in medical device regulatory submissions. This guidance applies to physics-based, mechanistic, or other first principles-based models. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.

Credibility of Computational Models program: Research on Computational Models and Simulation Associated with Medical Devices| 27 January 2022

The FDA is extending the comment period  on the document published on December 23, 2022 (86 FR 72969) by 30 days. Submit either electronic or written comments on the draft guidance by March 24, 2022.

On December 23, 2021, the FDA issued the draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. This draft guidance will be open for public comments at www.Regulations.gov under docket number FDA-2021-D-0980. The FDA developed this draft guidance document to assist industry and FDA staff in assessing the credibility of Computational Modelling and Simulation (CM&S) used in medical device regulatory submissions.

This draft guidance, when finalized, is intended to help improve the consistency and transparency of the review of CM&S evidence, to increase confidence in the use of this evidence in regulatory submissions, and to facilitate improved interpretation of this evidence submitted in regulatory submissions reviewed by FDA staff. This draft guidance is not for implementation.

Medical Device Types to Help Determine Section 506J Notification Obligations|14 January 2022

This table is part of  notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised) – Immediately in Effect Guidance for Industry and Food and Drug Administration Staff. This table represents the FDA’s recommendations based on its current understanding of the device types and corresponding product codes that manufacturers should consider to determine whether they are required to notify FDA under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) during the COVID-19 pandemic. This table is not exhaustive, and FDA intends to update this table as the COVID-19 pandemic evolves.

Device TypesExamplesProduct Code(s)
Clinical Chemistry ProductsCritical Care Tests, Tests That May Monitor COVID-19 ProgressionCEM, CEO, CFA, CGL, CGX, CGZ, CHL, CIC, CJY, JFL, JGJ, JGS, KHP, KHS, LFR, NBW, PZI, CGR, CIG, CIT, CIX, CJE, JFM, JFT
Dialysis-Related ProductsDialysis Accessories, DialyzersFID, PQK, FIG, FIR, FJD, FJF, FJI, FJK, FJT, FKB, FKJ, FKO, FKR, FLA, KDJ, KDL, KDN, KOC, KPF, KPO, LFK, LLB, MLW, MPB, MQS, MSD, MSY, NQJ, NYU, PEH, PFH, PKI, PPJ, FIL, FKP, FKQ, KDI
General ICU/Hospital ProductsAir Purifiers, Beds, Cleaning Products, Feeding Tubes, GI CathetersFRA, FRF, FNJ, FNK, FNL, FPO, KMG, MDZ, MEC, PSB, PSC, KGC, KNT, BSS, PIF, EZL, EOQ, KTI, PSV, FKK, KOD, FRR, LGM, LGN, PEZ, PWQ, FMK, NGT
Hematology ProductsOxygenation Tests, Clotting TestsDAP, GJS, GKR, JKS, JPA, MVU
Infusion Pumps and Related AccessoriesInfusion Pump Accessories, PumpsFMG, FOX, FOZ, FPA, FPB, FPK, KPE, KZD, LDR, LJS, LJT, MJF, MRZ, OJA, PND, PTI, FRN, MEA
Microbiology ProductsFlu Assay and MediaDCK, OEP, OTG, OZE, PSZ, QDS, QKP
Needles and SyringesN/AFMF, FMI, MEG, MMK
Personal Protective Equipment (PPE)Gloves, Gowns and Surgical Apparel, Respirators, Surgical MasksFMC, KGO, LYY, LYZ, LZA, LZB, LZC, OCP, OIG, OPA, OPC, OPI, PXC, QDO, IWP, OXZ, FME, FXO, FXP, FXY, FXZ, FYA, FYB, FYC, LYU, OEA, BWP, FXW, FYE, FYF, MSH, NZJ, ONT, ORW, FXX, OUK
Sterilization ProductsEtO, Steam, Sterilization AccessoriesFLF, FLI, MLR, FLE, KCT, MED
Testing Supplies and EquipmentGeneric Analyzer, Reagents, Specimen Container, Specimen Collection, Transport Media, Swabs, VialsPFF, PPM, PFT, KDT, KDW, LIO, JSM, JSL, JSN, JTW, JTX, JSG, CBD, KXG, JKA, OYJ, QBD, QOF, JJH, JQW, KHO, LXG, NSU, OOI, JRC, GIM

Medical device Material Safety Summaries: ECRI Reports| 11 January 2022

The U.S. Food and Drug Administration (FDA) partnered with ECRI (originally founded as Emergency Care Research Institute), an independent non-profit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation. As part of the FDA’s ongoing commitment to promote the safety of medical devices, the FDA and ECRI are publishing these safety summaries for materials that are commonly used in implantable medical devices and the effects of those materials on patients over time.

Federal Register: Permanent Discontinuance or Interruption in manufacturing of a Device under the Federal food, Drug, and Cosmetic Act| 10 January 2022

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) require manufacturers to notify the FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in the supply of that device in the United States.

This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices during or in advance of a public health emergency. FDA is issuing this guidance to implement amendments to the FD&C Act by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to devise shortages and potential device shortages during or in advance of a public health emergency. This draft guidance is not final nor is it in effect at this time.

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act- Draft Guidance for Industry and Staff|10 January 2022

The Food and Drug Administration (FDA or Agency) is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356j), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to notifying FDA of a permanent discontinuance or interruption in the manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device during or in advance of a public health emergency.

UK

Notify the MHRA about a clinical investigation for a medical device| 17 January 2022

You may need to carry out a clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI marking for your medical device. You must inform the MHRA if you are planning to do this at least 60 days before starting your investigation.

Regulating Medical Devices in the UK| 1 January 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

This guidance provides information on the UK system, including:

  • getting your device certified
  • conformity marking your device
  • registering your device with the MHRA

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland. In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices.

Register Medical Device to place on the market| 1 January 2022

All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).

In Great, Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be placed on the market and registered with the MHRA.

New proposals for the future of UK clinical trial legislation| 17 January 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has today launched a public consultation on a set of far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. Clinical trials are vitally important for achieving advances in medical treatment. Clinical trials may be conducted for a range of purposes, for example to test whether a new treatment or combination of treatments is safe and effective, or to explore new ways to use existing medicines – as has been seen with the rapid introduction of new vaccines and therapeutics for COVID-19.

IRELAND

European Commission public consultation: Product with an aesthetic or non-medical purpose- safety requirements| 19 January 2022

The European Commission has published a draft of the common specifications for products with an aesthetic or non-medical purpose listed in Annex XVI of Regulation (EU) 2017/745. Feedback can be submitted during a period of public consultation, which will remain open until 11 February 2022.

The draft document sets out general requirements relating to risk management and information for safety, as well as specific requirements relating to contact lenses, implants, fillers, body sculpting equipment, body hair removal devices and electrical brain stimulators.

SWITZERLAND

Obligations for authorised representatives, importers and distributors | 06 January 2022

The Medical Devices Ordinance (MedDO; SR 812.213) sets out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor.

MU600_00_016e_MB Obligations Economic Operators CH (PDF, 335 kB, 30.12.2021)

Good Practice for the reprocessing of medical device for Swiss health facilities| 04 January 2022

Publication of the “Good practice for the reprocessing of medical devices for Swiss health facilities” (GPA), version 2022.

The legal requirements pertaining to reprocessing are set out in Art. 72 of the Medical Devices Ordinance (MedDO). Medical devices intended for multiple use or single-use that are not supplied in sterile condition must be reprocessed before use in accordance to the current state of technology and science, taking account of the manufacturer’s instructions and the requirements of good hygiene. 

Suitable methods must be used for reprocessing, which generally comprises cleaning, disinfection, functional inspection, packing, sterilisation, transport and storage. These methods must have been validated in accordance with the state of technology and science, and their efficacy must have been demonstrated and be transparently and reproducibly guaranteed within the framework of an appropriate quality management system.

SLOVENIA

Safety Notices for Medical Devices- December 2021 | 18 January 2022

The Safety Corrective Notice is a written notification from the manufacturer or authorized representative of the medical device manufacturer of the safety corrective measures that need to be put in place to ensure that the devices are safe to use and thus reduce the risk of adverse events.

The manufacturer of the medical device or the manufacturer’s authorized representative must inform both the JAZMP and the users of the medical device in writing of the safety corrective measures, and the manufacturer must ensure that all users are informed immediately.

BRAZIL

Medical devices: Anvisa provided new subject code for data submission| 10 January 2022

Anvisa informs that, as of this Monday (1/10), the sending of information on technical attributes of medical devices selected for economic monitoring by the Agency must be carried out exclusively through the Request System, by subject code 80285 – G ecor – Submission of technical attributes of medical devices (health products).   

It is noteworthy that the measure is in accordance with the  Resolution of the Collegiate Board (RDC) 478/2021 , which provides for the economic monitoring of medical devices. The new subject code was created in compliance with article 21 of the standard.   

According to the Resolution, companies that hold the registration of monitored medical devices must use the new subject code to send technical attribute information in the following situations :  

  • when a new registration is granted, within 60 days after publication;  
  • at the time of revalidation of the registration; and whenever post-registration changes are made that include new models, change or include information related to the technical attributes of the medical device, within a period of up to 60 days after the post-registration change is granted.   

LATVIA

Latest information about clinical trials information system (CITS) | 17 January 2022

In the context of the new Clinical Trials Regulation an informative presentation on Clinical Trials Information System (CTIS) has been prepared and is available here. CTIS will be the single entry point for submitting clinical trial information in the EU and the European Economic Area (EEA).

December Newsletter

EU REGULATIONS

MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022

Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state[A1] s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR and no later than 26 May 2024 under certain conditions. The mentioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance with respect to all the applicable requirements relating to the devices it has certified. Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3) of the MDR.

MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies | 15 February 2022

Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices [A1] (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes IVDs. Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis.

This document aims to provide guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of the IVDR. This guidance also describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs. It also includes guidance on:

  • relevant information to be included within the notified body’s procedures,
  • the content of the required pre-agreed conditions and detailed arrangements between the notified body and the manufacturer,
  • guidance on the frequency of samples of devices or batches of devices to be sent to the EURL.

Update – MDCG 2021-21 Rev.1 – Guidance on performance evaluation of SARS-CoV-2 In Vitro Diagnostic Medical Devices | 15 February 2022

The guidance document concerns performance evaluation of SARS-CoV-2 In Vitro Diagnostic Medical Devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens, and detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs. The guidance is addressed to all interested parties, including the manufacturers, as well as notified bodies and competent authorities, authorised representatives, other market operators, professional and patient associations. The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.

Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR | 07 February 2022

A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. The MDR was envisaged to apply from 26 May 2020. In contrast, the IVDR has a date of application of 26 May 2022. In March 2020, the Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR. The plan listed priority actions for the Member States and Commission services, to be monitored at the level of the MDCG. The MDR joint implementation plan recognised the need to carry out a similar exercise for the IVDR. The present document therefore proposes a draft joint implementation plan for the IVDR.

IRELAND

Guide to Classification of a Medical Device | 16 February 2022

This document is a guide for classifying medical devices covered by the European Directive 93/42/EEC, as amended and the related Irish regulation, S.I. No. 252 of 1994, (‘the Regulation’). It outlines the process for classifying medical devices and explains how to seek clarification on classification of a medical device. This guide sets out, inter alia, the reasons for classification and the routes to correctly qualify or classify a product under the Medical Device Regulation 2017/745 (MDR).

AUSTRIA

Clinical investigations with medical devices | 04 February 2022

As of 28 January 2022,[A1]  a new fee regulation of the BASG was put into force. From this date new fees apply for:

  • clinical investigations of medical devices according to Regulation (EU) 2017/745
  • performance evaluation studies of in-vitro diagnostics according to Directive 98/79/EC and
  • amendments of clinical investigations of medical devices according to Directives 90/385/EEC and 93/42/EEC.

The electronic registration form is mandatory for a proper initial application for clinical testing of a medical device or performance assessment of an in vitro diagnostic medical device.

The following situations could potentially block [A2] the processing of an initial application or amendment and will result in an immediate e-mail response to the applicant that the procedure cannot be further processed:

  • Missing or corrupted BASG application form (PDF and XML[A3] )
  • No final positive ethics vote available for the overall study
  • Clinical investigation plan, investigator’s brochure or patient information(s) are missing or do not comply with the versions in the final ethics committee opinion

The applicant is then also granted a period of 10 days for correction or submission of documents. In justified cases an extension can be requested for up to 20 days.

ITALY

Expenses for promotional activities of medical devices | 24 February 2022

All companies that produce or market medical devices, must send the declaration relating to the total amount of expenditure incurred in the year 2021 to the Ministry of Health, for promotional activities by 30 April 2022. Information about the declaration and payment is available here.

In Vitro Diagnostic Medical Devices Regulation (EU) 2022/112 | 03 February 2022

The Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 in relation to the transitional provisions for certain medical-diagnostic devices has been published in the Official Journal of the European Union vitro and the deferred application of conditions concerning in-house manufactured devices.

With this document we are moving towards a progressive introduction of the Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices. Regulation (EU) 2022/112 does not modify the requirements of Regulation (EU) 2017/746 in substance, but modifies its transitional provisions (Article 110).

No changes are foreseen for CE marked devices that do not require the intervention of a notified body or for “new” devices, i.e., those which have neither a certificate from a notified body nor a declaration of conformity pursuant to current directive 98/79 / EC.

For these types of devices, Regulation (EU) 2017/746 will apply from May 26, 2022, as envisaged. There is also a delay in application of the requirements for in-house devices. Regulation (EU) 2017/746 introduced a set of common rules for such devices, which include requirements for the justification of their use and rules to ensure their safety and performance, such as an adequate quality management system.

CZECH REPUBLIC

Modification of the KZ module in RZPRO | 25 February 2022

The KZ module in Registry for Medical Devices (RZPRO) was modified so that in the case of submitting an application for permission to change KZRO and applications for the continuation of KZ, separate file marks were generated. Therefore, the mentioned proceedings will no longer be conducted under the file number that was assigned to the KZ permit application. In the field of clinical trials, it is necessary to distinguish between individual procedures and therefore a separate file must be kept for each. A manual of the changes can be found here.

BELGIUM

Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market | 24 February 2022

The European Regulation 536/2014 (Clinical Trial Regulation, CTR) came into force on 31 January 2022 and allows the packaging/labelling of investigational medicinal products already on the market not to be adapted for the clinical trial, except under special circumstances. 

LATVIA

Information about Clinical Trials Information System (CTIS) | 17 January 2022

Based on the new Clinical Trials Regulation, an informative presentation on Clinical Trials Information System (CTIS) has been prepared, and can be accessed here.

UNITED KINGDOM

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland | 07 February 2022

The guidance explains about obtaining a Written Confirmation for each shipment of Active Substances manufactured in Great Britain (England, Wales and Scotland) that is exported to the EEA or Northern Ireland. Importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation is accepted from the following list of countries:

  • European Economic Area (EEA) countries
  • USA
  • Japan
  • Republic of Korea
  • Brazil
  • Australia
  • Israel
  • Switzerland
  • Northern Ireland

AUSTRALIA

Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia | 22 February 2022

The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. TGA released this Discussion Paper seeking feedback on potential changes to mandatory reporting of medical device adverse events – as part of the reform program.

The discussion paper can be found here.

Special Access Scheme (SAS)| 18 February 2022

The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient. Therapeutic goods that are not included in the ARTG (and are not otherwise exempt from being in the ARTG) are described as ‘unapproved’. SAS applications and notifications can only be submitted by certain registered health practitioners. Notifying or submitting an application: SAS Online System

Consultation on potential regulatory options for ‘export only’ biologicals| 15 February 2022

The Therapeutic Goods Administration (TGA) conducted a public consultation on potential options for the regulation of biologicals manufactured in Australia for export only (and not for supply in Australia). Currently, biologicals included in the Australian Register of Therapeutic Goods (ARTG) can be exported, but they are not permitted to vary from the product supplied in Australia. This means that ‘export only’ biologicals cannot have different indications, release specifications, or labels to the product approved by the TGA, even if the importing country has assessed and approved the product independently.

  • Opening date: 15 November 2021
  • Closing date: 22 December 2021

Importing COVID-19 Rapid Antigen Tests (RATs) | 11 February 2022

Only the approved supplier (sponsor) or their agent, as entered on the Australia Register of Therapeutic Goods (ARTG), can import rapid antigen tests (RATs) into Australia for commercial supply. The RATs must be on the ARTG, under the name of the supplier, prior to importation. Any RATs imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import. Many therapeutic goods, including RATs, are available both in Australia and overseas. When a legitimate version of an overseas product is imported with the goal of being marketed in the Australian market, this is known as parallel import. These goods may be genuine and made by the firm listed on the packaging, but they are not the version of the product that has been assessed for the Australian market and entered into the ARTG. Parallel imports may or may not satisfy the same quality and safety criteria as Australian counterparts, and the TGA has not inspected them. Parallel imports are unapproved items that should not be imported for commercial purposes into Australia.

ACMD meeting statement, Meeting 65| 10 February 2022

The Therapeutic Goods Regulations of 1990 established the Advisory Council on Medical Devices (ACMD), which is a statutory advisory committee. The TGA’s decision-making and other regulatory processes are aided by the committee’s independent expert input on specific scientific and technical matters. Synthetic ligament applications for Achilles Tendon, Anterior Cruciate Ligament, and Rotator Cuff injuries, which were considered at ACMD 53, were withdrawn, and there were no other decisions made for these items. At the 65th ACMD meeting, whether the benefits outweighed the risks for the devices and whether adequate evidence had been provided to demonstrate safety and performance through compliance with the Essential Principles, the committee considered Personalised Medical Devices and the following devices for discussion:

  • an application for a bone and soft tissue filler that can be used with infections
  • an application for a revision knee replacement system.

USA

About Manufacturer and User facility Device Experience (MAUDE) | 18 February 2022

Manufacturer and User Facility Device Experience (MAUDE) database represents reports of adverse events involving medical devices. The searchable database data contains the Medical Device Report [A1] [A2] (MDR) data of last 10 years. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

The public may search the database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE data is current through the end of the previous month. The FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed due to technical [A3] or clerical difficulties.

Medical Device Reporting (MDR): How to Report Medical Device Problems | 18 February 2022

The FDA is extending the comment period  on the document published December 23, 2022 (86 FR 72969) by 30 days. Submit either electronic or written comments on the draft guidance by March 24, 2022.

On December 23, 2021, the FDA issued the draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. This draft guidance will be open for public comments at www.Regulations.gov under docket number FDA-2021-D-0980. The FDA developed this draft guidance document to assist industry and FDA staff in assessing the credibility of Computational Modelling and Simulation (CM&S) used in medical device regulatory submissions.

This draft guidance, when finalized, is intended to help improve the consistency and transparency of the review of CM&S evidence, to increase confidence in the use of this evidence in regulatory submissions, and to facilitate improved interpretation of this evidence submitted in regulatory submissions reviewed by FDA staff. This draft guidance is not for implementation.

Center for Devices and Radiological Health Appeals Processes | 17 February 2022

The Food and Drug Administration (FDA / Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with certain Center for Devices and Radiological Health (CDRH) appeals processes.

Establishment Registration and Device Listing for Manufacturers and Importers of Devices | 07 February 2022

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with establishment registration and device listing for manufacturers and importers of devices.

BRAZIL

ANVISA publishes standard on simplified analysis of clinical research | 23 February 2022

On 16 February 2022, in the Official Gazette (D.O.U), ANVISA published the Resolution of the Collegiate Board (RDC) 601/2022, which provides simplified analysis, on an exceptional and temporary basis, of clinical research petitions.  the standard deals with a regulatory measure to cope with an emergency, as provided for in item I, art. 39 of Ordinance 162/2021. The measure seeks to quickly release petitions for medical research, provided that these petitions have been authorized by regulatory authorities of remarkable recognition.

ANVISA approves the registration of the first self-test for Covid-19 in Brazil | 17 February 2022

To grant registration, ANVISA analyses several technical requirements, including usability and risk management, which serve to adapt the product to use by lay people, ensuring greater security. Guidelines on usage of the product can be found here.

ANVISA prohibits collection kit for testing and diagnosis of Covid-19 without registration | 16 February 2022

ANVISA clarifies that these products can only be marketed in the country after registration.

Regulating remote inspections| 14 February 2022

ANVISA published a document with questions and answers on the regulation of remote inspections of imported goods and products subject to sanitary surveillance in ports and airports in the country by the modality of the Integrated System of Foreign Trade (SISCOMEX). The objective is to allow the regulated sector to carry out inspections remotely on goods whose Import Licensing (IL) is under analysis by the Agency. According to the rules of Resolution of the Collegiate Board (DRC) 597/2022 published in the Official Gazette (D.O.U.), the standard will enter into force on 2 March 2022. 

CANADA

Publication of third Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers, and users | 21 February 2022

To accelerate access to certain medical equipment in Canada during the pandemic, Health Canada issued two interim rules on the importation and sale of medical devices for use in respect to COVID-19. On March 18, 2020, the first interim order was issued, and on March 18, 2020, the second interim order was issued. As Interim Order No. 2 was set to expire on 1 March 2022, Health Canada has put in place a third interim order. The first and second interim orders expedited the regulatory procedure for approving the importation or sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19 while ensuring that safety, efficacy, and quality requirements were satisfied. The goal of Interim Order No. 3 is to keep the same flexibility that Interim Order No. 2 provided. Unless otherwise specified, all application conditions remain the same as in the second interim order. As a result, all active authorizations and expanded use indications under Interim Order No. 2 will be continued under Interim Order No. 3. The manufacturer will not be obligated to take any action. Manufacturers of permitted devices under Interim Order No. 2 may continue to import and sell their products in Canada. Any terms and conditions imposed on an interim order authorisation issued under Interim Order No. 2 remain in effect. Manufacturers must continue to operate under the same conditions as before. Interim Order No. 3 will remain in place for up to 1 year.

Regulations to allow exceptional importation of medical devices to address shortages as of 2 March 2022 | 16 February 2022

Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021, come into force on March 2, 2022, which will allow the exceptional importation and sale of medical devices to help address shortages in Canada. Current provisions allowing the exceptional importation and sale of devices related to COVID-19 are set out under Interim Order No. 2 which will no longer be in effect after 1 March 2022. The amendments to the MDR allow medical devices that would not otherwise meet Canada’s regulatory requirements to be imported and sold. However, these devices must meet the following conditions:

  • the device is a substitute for one that is in shortage or at risk of being in shortage
  • the device is authorized for sale in another jurisdiction
  • the device is manufactured to quality standards comparable to those in the MDR
  • the importer has a medical device establishment licence (MDEL)
  • the importer informs Health Canada at least 5 business days before importing the device

SINGAPORE

Guidance on Medical Device Product Registration | 07 January 2022

The Health Sciences Authority (HSA) has amended the guidance document meant to assist applicants in the registration of medical devices under the Act and Regulations. This guidance document describes the procedures and general requirements for the submission of an application for a new Product Registration for medical devices. The document can be found here.

Guidance on Grouping of Medical Devices for Product Registration (Revision 2) | 07 January 2022

This version of GN-12 guidance document applies to all medical device registration applications submitted to HSA. The grouping criteria described in the GN-12-1 and GN-12-2 shall be strictly adhered to in submitting your medical devices for registration. This document is meant to provide guidance on the device specific criteria in determining whether certain models of specific medical devices can be included together and submitted in one product registration application.  Grouping of medical devices for product registration facilitates the inclusion of multiple devices in one application.

BAHRAIN

Medical devices registration fast-track communication and delivery of services | 06 February 2022

The National Health Regulatory Authority (NHRA) announced a partnership with Adliya Business Center CO. W.L.L (ABC) as a private agency for instant communication and delivery of services for medical device registration, to help applicants who are having trouble preparing the required documents, and to speed up the registration process. Applying through Adliya Business Center CO. W.L.L (ABC) is optional, as applicants can submit directly to NHRA.

Medical devices registration fast-track communication and delivery of services | 06 February 2022

In accordance with decision (48) of 2020 related to medical devices regulations, The National Health Regulatory Authority (NHRA) notified all the importers and shop owners, especially those who are selling medical and cosmetic lenses, about the necessity of verifying that the lenses are approved by NHRA.

Cases that will not be included in the medical device’s regulation | 06 February 2022

Based on the resolution no. (48) for the year of 2020, NHRA clarified that the following medical devices will not be subjected to registration:

  1. Medical device imported for healthcare facilities for:
  2. Emergency
  3. A single time and not planned to be imported on a regular basis 
  4. Medical devices imported for research and educational purposes
  5. Personal imported medical devices
  6. Custom-made medical devices or order for specific patient 
  7. Samples for exhibition and conferences

INDIA

Regulation of sale of medical devices via registration of premises under MDR, 2017 | 09 February 2022

A draft of certain rules further to amend Medical Device Rules 2017, published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. The draft rules can be accessed here, page 7.