EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15 November 2021
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that 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in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates.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 European Commission is not in a position to require the use of the NBs & Certificates module until EUDAMED is fully functional according to the Medical Device Regulation.
Therefore, in EUDAMED, NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) only on voluntary basis if all the parties referenced in the certificates are first registered, also on a voluntary basis, in this database. The parties to be registered would include the manufacturer, the authorised representative (where applicable), and/or the system procedure pack producer and the Basic UDI-DI(s) referenced. However, additional national requirements cannot be excluded.
EUDAMED UDI/Devices registration module – Relevant documents and information| 8 November 2021
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Therefore, additional national requirements on registrations cannot be excluded.
Guidance on labelling requirement for Medical Devices| November 2021
The Medical Devices Regulation 2017/745/EU (‘MDR’) has new requirements that ask for various kinds of information to be indicated on the label of medical devices. Originally, the present guidance was developed to support compliance with labelling requirements of the MDR in a harmonised manner before the publication of ISO 15223-1: 2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements, which has now been published (July 2021). Therefore, the present guidance has been updated to align with the new ISO 15223-1:2021.
BELGIUM
Deadlines for the submission of dossiers during end-of-year period | 10 November 2021
During the end-of-year period, the FAMHP will be closed from Monday 27 December 2021 through Friday 31 December 2021. Deadlines have been set for the submission of different types of dossiers. Dossiers for the Research and Development Division (human use) Tuesday 14 December 2021 is the final date to submit the following dossiers: • initial applications for phase I monocentric Directive CTA dossiers; • substantial amendments for phase I monocentric Directive CTA dossiers; • substantial modifications for phase I monocentric CTR pilot dossiers.
FINLAND
Supervision of devices referred to in Annex XVI of the Medical Device Regulation to begin in autumn 2022 | 2 November 2021
The requirements applying to the devices referred to in Annex XVI of the Medical Device Regulation are due to enter into force in autumn 2022. The decisions issued by the European Commission will affect the timetable. According to current information, the common specifications related to the supervision of the devices referred to in Annex XVI will be completed in the European Commission in early 2022. The transition period for organising the supervision is six months from the publication of the common specifications.
Operators affected by this must follow the information communicated by the Commission and Fimea.
In Finland, Fimea is the supervisory authority for the devices listed in Annex XVI of the Regulation. In addition, new national legislation will supplement the Regulation.
SLOVENIA
Procedure for entering a test intended for self-testing in the central database of medicinal products (CBZ) | 24 November 2021
Only tests intended by the manufacturer for end users, non-experts for self-testing, are intended for registration in the CBZ. For such tests, the mandatory certification process involves a notified body established in the EU that is accredited for certification under Directive 98/79 / EC or Regulation (EU) 2017/746. In the case of a successful conformity assessment procedure, such tests shall be accompanied , in addition to the EC declaration of conformity, by the CE certificate of the notified body . In addition to the CE marking, the test also includes the four-digit number of the notified body that carried out the assessment. The enrolment process is carried out by submitting documentation to the Ministry of Health. The documentation must contain: • EC declaration of conformity indicating that the test is intended for self-testing (risk class: IVD – self-testing, indicating the number of the CE certificate) • CE certificate from a notified body established in the EU (with reference to Directive 98/79 / EC or Regulation (EU) 2017/746) • Original instructions for use • Instructions for use in the Slovenian language – please note that the translation must be the same as the original instructions with all references • If the translation of the instructions into Slovenian is performed by your company, provide a written authorization from the manufacturer , in which he expressly authorizes you to translate the instructions into Slovenian and undertakes to inform you of any changes and new editions of the instructions for use. If you have all the above documentation, send it to the general address of the Ministry of Health.
Information on Rapid Antigen Tests that determine the presence of SARS-COV-2 Antigen| 12 November 2021
While increasing the use of rapid antigen tests that detect the presence of SARS-CoV-2 antigen, JAZMP wishes to warn consumers and other test users to be careful when selecting a test that the test is compliant with the legislation and suitable for use in the target user group. On the market, among the products offered to consumers, we also perceive tests that are intended only for use by professional users, accredited laboratories and qualified staff (“Professional Use Only”). Such tests are not suitable for self-testing, as the use of a non-compliant test or a test that is not certified for use by non-experts may lead to an erroneous test result.
Safety Notices for Medical devices| 12 November 2021
The notifications on safety corrective measures for medical devices received by JAZMP from manufacturers or authorized manufacturers’ representatives in October 2021 are available on the JAZMP website. They are available at the following Link.
ITALY
Medical devices, indications relating to the application of Regulation(EU) 2017/745 | 17 November 2021
The General Directorate of Medical Devices and Pharmaceutical Service of the Ministry of Health clarifies, with the Circular of 12 November 2021, some aspects necessary for the application of Regulation (EU) 2017/745.
The indications concern the provisions on the national database, manufacturers of custom-made devices , legacy devices , notified bodies, advertising, the use of harmonized standards, the products of Annex XVI of Regulation (EU) 2017/745 , tariffs and penalties.
The Circular has the purpose of guaranteeing a uniform and consistent application of the Regulation until the full functioning of Eudamed and during the period of validity of the CE markings pursuant to the directives.
GERMANY
Current Processing Statistics of the Federal Institute for Drugs and Medical devices | 17 November 2021
Processing Statistics: Applications for Authorization and Registration
From the date of application of the Regulation (EU) 2017/745 (MDR) on May 26, 2021, the reporting of serious adverse events (SAEs) and device deficiencies must be carried out in accordance with the MDR in conjunction with the Medical Device Law Implementing Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) for all clinical investigations that must be applied for or notified to the federal higher authority (“Bundesoberbehörde”).
This also applies to already initiated (ongoing) clinical investigations for which SAEs were previously to be reported to the higher federal authority in accordance with the MPSV.
IRELAND
In-house manufacturing of in-vitro diagnostic medical devices – stakeholder survey | 22 November 2021
The HPRA have published a survey to collect information about how in-house manufacturing of in vitro diagnostic medical devices will be impacted by the In Vitro Diagnostics Regulation (IVDR). We invite medical laboratory scientists and personnel who work with in vitro diagnostic medical devices to complete the survey, which is available at this link: HPRA IVD In-house Manufacturing Survey.
This survey is a follow-up to a preliminary survey conducted by the HPRA in 2020 to gather information on devices manufactured, modified and used only within health institutions, known as ‘in-house devices’. The information collected will be used to assist in the implementation of IVDR.
Applying for a certificate of free sale | 4 November 2021
The HPRA has published updated information relating to export certification, including information about applying for a certificate of free sale for medical devices. In this update, the HPRA has: • Provided an overview of the legal basis for issuing certificates of free sale; • Clarified the process for applying for certificates of free sale under Directive 93/42/EEC (MDD) and Regulation 2017/745 (MDR); • Developed a checklist to assist stakeholders when applying for a certificate of free sale.
SWITZERLAND
Procurement of medical devices in healthcare institutions| 15 November 2021
Swissmedic recommends that health institutions include a check for conformity with the relevant regulatory requirements during the procurement process for medical devices and that they check and keep the documentation on product conformity (declaration of conformity and EC certificates) to be checked and stored.
Information and help on the procurement of medical devices in health institutions:
Notify the MHRA about a clinical investigation for a medical device |16 November 2021
A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.
If possible, please provide the MHRA with advanced notice of your intention to submit a clinical investigation by emailing [email protected] with some basic details about the investigational device, the intended population, the type of study, and estimated application date. Please provide as much notice as possible. An advanced notice is helpful to the MHRA, however is not a substitute for the formal clinical investigation notification.
USA
Webinar on 14 December 2021 on Final Rule for Medical Device De Novo Classification | 24 November 2021
On Tuesday, December 14, 2021, at 1:00 pm ET, the U.S. Food and Drug Administration (FDA), will host a webinar for stakeholders interested in learning about the final rule, Medical Device De Novo Classification Process, and associated guidance document updates. This final rule describes the FDA’s De Novo classification process that provides a pathway for certain novel medical devices to be classified as class I or class II, rather than automatically as a class III device, which requires premarket approval (PMA).
Federal Register: General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System | 22 November 2021
The Food and Drug Administration (FDA or we) is classifying the general laparoscopic power morcellation containment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the general laparoscopic power morcellation containment system’s classification. They are taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device.
Reclassification | 19 November 2021
The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device’s safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III. The regulatory class of a device type, as defined in Section 513(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(a)) and its implementing regulation at 21 CFR 860.3, may be changed through the process of reclassification. The main purpose of reclassification is to apply the appropriate level of regulatory controls for a device type based on the most current information regarding its safety and effectiveness. Reclassification is applied to a device type and not an individual device.
The sections of the FD&C Act that address device reclassification are: • Section 513(e) – Applies to classified devices, except those devices currently classified into class III under Section 513(f)(1). • Section 513(f)(3) – Applies to post amendments devices classified automatically into class III under Section 513(f)(1).
FDA in Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II | 19 November 2021
The FDA issued two final orders, reclassifying certain HCV diagnostic tests from class III to II. These orders allow these HCV tests to use FDA’s 510(k) pathway rather than the PMA pathway.
The two types of HCV diagnostic tests being reclassified are nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA and certain HCV antibody devices intended for the qualitative detection of HCV.
Federal Register: Effective Date of Requirement for Premarket Approval for Blood Lancets | 19 November 2021
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.
Federal Register: General and Plastic Surgery Devices; Reclassification of Blood Lancets | 19 November 2021
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for multiple patient use, from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is reclassifying these four types of blood lancets on its own initiative based on new information.
Federal Register: Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests| 19 November 2021
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, post amendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named “hepatitis C virus (HCV) antibody tests.” FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.
Federal Register: Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests| 19 November 2021
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, post amendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named “nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests.” FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.
Federal Register: Administrative Detention and Banned Medical Devices| 19 November 2021
The Food and Drug Administration (FDA or the 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 for administrative detention and banned medical devices.
21 CFR section
Number of respondents
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
Administrative detention reporting requirements—800.55(g) and (h)
1
1
1
25
25
Banned devices reporting requirements—895.21(d)(8) and 895.22(a)
26
1
26
16
416
Total
441
Table 1—Estimated Annual Reporting Burden
21 CFR section
Number of recordkeepers
Number of records per recordkeeper
Total annual records
Average burden per recordkeeping
Total hours
Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k)
1
1
1
20
20
Table 2—Estimated Annual Recordkeeping Burden
Medical Device Development Tools (MDDT) | 16 November 2021
The FDA has qualified MDDTs for cardiovascular, neurology, plastic surgery, automated insulin dosing, and imaging devices, as well as crosscutting tools for active implanted medical devices and cybersecurity. The following table lists MDDTs qualified by the FDA, along with a Summary of Evidence and Basis of Qualification (SEBQ) for the tool. This summary includes: • A brief description of the tool • The qualified context of use • A general summary of evidence to support qualification • A brief assessment of the advantages and disadvantages of using the tool • Information on how to contact the tool developer about accessing the tool Medical device sponsors submitting a marketing application that relies on a qualified MDDT may include the MDDT submission number in the cover letter or the FDA CDRH Premarket Review Submission Cover Sheet form 3514 (Section F or J). The MDDT submission number for each qualified tool can be found in the SEBQ.
Federal Register: Content of Premarket Submissions for Device Software Functions | 3 November 2021
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Content of Premarket Submissions for Device Software Functions.” This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). When final, this document will replace FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued on May 11, 2005, and it will update FDA’s thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions. This draft guidance is not final nor is it in effect at this time.
BRAZIL
Anvisa informs the end of the rule on the import of medicines and medical devices | 18 November 2021
ANVISA informs that the Resolution of the Collegiate Board (RDC) 483/2021, on requirements for the importation of new medical devices and drugs identified as priority for use in health services, has not been extended, as informed at the Public Ordinary Meeting 22, of 10 November 2021.
The norm lost its effects on November 13th. The resolution was issued on an exceptional and temporary basis in March 2021, due to a critical moment of the Covid-19 pandemic in the country. At that time, there was a vertiginous increase in the number of people hospitalized in intensive care units (ICUs), with a consequent shortage of drugs in the Brazilian market, especially those used for sedation and anaesthesia for orotracheal intubation.
Contribute to the Design Control Guide for Medical device Manufacturers | 18 November 2021
The guide is an adapted and edited translation of the IMDRF GHTF SG3 Design Controls Guidance for Medical Devices Manufacturers document. Your goal is to help manufacturers of medical devices to understand the d system requirements and quality for the control and development of projects recommended by the Board Resolution (RDC) 16/2013 , through the interpretation of terminology and the explanation of regulatory concepts in practical terms for implementation in your Quality Management System.
AUSTRALIA
Frequently Asked Questions (FAQs) on reclassification of medical devices | 22 November 2021
Reclassification of medical devices frequently asked questions.
Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous system | 22 November 2021
This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021, medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS)will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.
Reclassification of medical devices that administer medicines or biologicals by inhalation | 22 November 2021
This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021, medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).
Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin | 22 November 2021
The purpose of this guidance is to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations. From 25 November 2021, some medical devices that are substances for introduction into the body will be required to be reclassified. The new regulatory requirements will also include: • more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device • conformity assessment documents demonstrating procedures appropriate for their classification • a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
Reclassification of spinal implantable medical devices | 22 November 2021
The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements. From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include: • more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device • conformity assessment documents demonstrating procedures appropriate for their classification • a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
Consent for Non-compliant Medical Device(s) – Frequently Asked Questions | 22 November 2021
Consent to import, supply or export a medical device that does not comply with the Essential Principles – frequently asked questions.
Consent to supply medical devices that are non-complaint with the Essential Principles (EPs) | 18 November 2021
If you are a sponsor and supply a medical device that has become non-compliant with the EPs you will need TGA approval to continue to supply them. You will need to use the Consent to Supply application form. The TGA is currently modernising the Consent to Supply application process, moving from a paper form to an online form in two phases, with Phase 1 -Interim online form on the TGA Consultation Hub, completed earlier this year. Phase 2 of the project is now ready for release with the online form moving to the TGA Electronic Business Services (tBS) portal with additional functionality including the ability for sponsors to view their current and previous applications.
Medical Device Incident Reporting (MDIR) guide | 12 November 2021
This document is a user guide for sponsors in regard to the MDIR system. It outlines the initial steps to access the MDIR system and then describes how to use the system, with step by step instructions and examples as required. The MDIR system has been enhanced to enable sponsors and manufacturers to monitor and track device incident reports. You will be able to lodge reports electronically, update previously reported incidents with additional information, review the status of reports, update initial and follow-up reports, and view past reports. All submitted reports and updates are received immediately by the Therapeutic Goods Administration (TGA).
Adverse Event reporting | 12 November 2021
The primary function of post market event monitoring is to improve the health and safety of patients, health care professional, users, and others by reducing the likelihood of adverse events being repeated. Adverse event reporting allows the TGA to monitor medical device use, monitor their performance in the real world and identify trends that may indicate emerging safety and performance issues. These activities allow the TGA to take appropriate regulatory action to address these issues, thereby reducing the impact on the public.
It is an automatic condition of inclusion under 5.7 of the Therapeutic Goods (Medical Devices) Regulations 2002 that sponsors of a medical device report adverse events or near adverse events to the TGA Incident Reporting and Investigation Scheme (IRIS).
Medical devices reforms: Personalised Medical Devices| 5 November 2021
Prior to 25 February 2021, most personalised medical devices (PMD) met the definition of ‘custom-made’ and were exempt from the requirement to be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported or supplied (though they were subject to other regulatory obligations).
Following extensive consultation and liaison with other global regulators, the Therapeutic Goods Administration (TGA) developed a new regulatory framework for PMD. This new framework has been introduced by the Government to ensure an appropriate level of regulation is applied to PMD in order to manage the risk they may pose.
Custom-made medical devices | 4 November 2021
If a device you manufacture or import is impacted by this change and requires inclusion on the ARTG, there are transition arrangements in place until 1 November 2024 to allow you to complete this process.
RUSSIA
On November 15, the I All-Russian Forum with international participation “Circulation of medical devices NOVAMED-2021” began work in Moscow| 15 November 2021
On November 15, a two-day All-Russian Forum with international participation “Circulation of medical devices” NOVAMED-2021 “, organized by Roszdravnadzor, the Ministry of Health of Russia and the Ministry of Industry and Trade of the Russian Federation, opened in Moscow.
More than 600 delegates from Japan, Brazil, Australia, Kyrgyzstan, Belarus, Kazakhstan and 85 constituent entities of the Russian Federation took part in the event in person and remotely.
At the end of the plenary session, the results of the competition “Safety of medical devices – for the benefit of people” were summed up, organized by the Federal State Budgetary Institution “National Institute of Quality” of Roszdravnadzor.
CHINA
Updated on the development of therapeutics, vaccines, medical devices and test kits | 24 November 2021
The Ministry of Health, Labor and Welfare conducts prioritized and prompt examinations of new coronavirus-related drugs, medical devices (ventilators, etc.) and test kits.
New Regulations on Medical Device Management in Vietnam| 25 November 2021
On November 8, 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Devices (“Decree 98”). The new decree will take effect from January 1, 2022, replacing Decree No. 36/2016/ND-CP and its amendments on the same subject (“Decree 36”).
Classification of Medical Devices
Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the medical device. Under Decree 36, this responsibility was reserved for Vietnamese organizations qualified for medical device classification.
Clinical Trials of Medical Devices
Decree 98 provides stricter and more detailed requirements on clinical trials. Particularly, medical device trials will include three phases, in which phases 1 and 2 need to be finished before the product registration, while phase 3 will be conducted after the medical devices are approved for circulation, following the specific requirement from the authorities. This requirement aims to continue evaluating the safety and efficacy of medical devices after they are widely used in the community in line with their usage conditions.
Medical Device Registration
Similar to the current regulations, Decree 98 requires that medical devices must be registered with the Vietnamese authority (i.e., must obtain registration numbers) before being imported/manufactured for circulation in the Vietnam market. However, Decree 98 further stipulates new requirements.
Price Management
In an effort to control the price of medical devices, Decree 98 includes a new requirement in which registration number holders must declare the prices of their medical devices on the Portal of Medical Device Management before putting the medical devices on the Vietnam market; the actual prices must not be higher than the declared prices.
Importation of Medical Devices
Decree 98 sets out situations where medical devices without registration numbers must have import licenses. These include, among others, medical devices for scientific research, tests, trials, quality assessment, or training; medical devices for aid, humanitarian aid, gifts, fairs, exhibitions, displays, or product introduction; and medical devices meeting urgent needs for national defence, security, epidemic prevention and control, and overcoming consequences of natural disasters and catastrophes.
Medical Device Advertisement
Decree 98 completely removes the procedure for approval of medical device advertising contents. Instead, the holders of medical device registration numbers or their authorized entities will be responsible for publicly declaring the intended content and form of the advertising on the Portal of Medical Device Management before conducting the advertising.
The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021
To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. The length of the proposed transition periods depends on the type of device:
• Class D (High Risk Devices): until May 2025 and 2026 • Class C (High to Moderate Risk Devices): until May 2025 and 2026 • Class B (Moderate to Low-Risk Devices): until May 2027 • Class A (Low Risk Devices): until May 2027
Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation | 14 October 2021
The European Commission has proposed Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (IVDR) to prevent disruption in the supply of these essential healthcare products. The general application date of the Regulation remains 26 May 2022. In particular, the IVD Regulation will apply in full as of 26 May 2022 to CE marked in vitro diagnostic medical devices that do not require the involvement of a notified body (i.e., class A non-sterile devices which represent around 20% of the market) and to ‘new’ in vitro diagnostics (i.e., those not covered by a certificate or a manufacturer’s declaration of conformity issued prior to 26 May 2022).
MDCG: Guidance on classification of medical devices | October 2021
The purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements as the classification of medical devices in EU medical device legislation is a risk-based system considering the vulnerability of the human body and the potential risks associated with the devices.
MDCG 2019-6 Rev3: Requirements relating to notified bodies| October 2021
The document presents questions and answers on requirements relating to notified bodies under Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 under following categories: • Organizational and general requirements • Resources requirements • Process requirements
MDCG: Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC | October 2021
The MDCG set up an impromptu task-force regarding the application of transitional provisions laid down in Article 120(3) of Regulation (EU) 2017/745 (MDR), the consequential application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC. The report of the task force was forwarded to all MDCG working groups and MDCG agreed to publish the task-force report as MDCG guidance at its meeting on 19 October 2021.
MDCG: Questions and Answers on repackaging & relabeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2021
The document presents questions and answers about obligations introduced by Article 16(2) to (4) under Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. Article 16(1) of the Regulations outlines cases where the obligations of manufacturers also apply to importers, distributors or other natural or legal persons. Article 16(2) of the Regulations specifies the cases in which certain activities of importers and distributors are not considered modifications of a device, within the meaning of Article 16(1)(c).
Note: Article 16(2), (3) and (4) of the Regulations do not apply to operators subcontracted by the manufacturer (that may also qualify as importers or distributors), who carry out relabelling and/or repackaging activities on behalf and under the control of the manufacturer.
FRANCE
Regulatory developments impacting medical devices that contain cobalt | 01 October 2021
Cobalt, most often alloyed with other metals, is a natural metallic element that is used in the manufacture of many medical devices. As of 1 October 2021, cobalt is classified as a substance: carcinogen 1B, mutagen 2, toxic for reproduction 1B, pursuant to Delegated Regulation 2020/217 of the European Commission but the use of this metal in MDs is not prohibited by this delegated regulation. In accordance with EU MDR 2017/745, devices containing cobalt in a concentration greater than 0.1% by mass fraction (m/m) must now meet the new safety and performance requirements set out in point 10.4 of Chapter II of Annex I. As of 1 October 2021, manufacturers of an MD that contains cobalt must: • justify the use of cobalt; this can be done, for example, by explaining why another material cannot replace it • indicate the presence of cobalt by specific labelling on the MD • provide a leaflet informing of the residual risks
HUNGARY
EU Electronic Application Forms:Electronic application formseAF 1.25.0.0 version | 19 October 2021
The National Institute of Pharmacy and Nutrition (OGYÉI) informed the marketing authorization holders and applicants about the mandatory use of the electronic application forms eAF 1.25.0.0 starting from 1 November 2021 highlighting implementation of the Medical Device Regulation Art 2(1) of Regulation (EU) 2017/745 as the major change in the version.
ITALY
Medical devices: Update of the Q&A document relating to the requirements of notified bodies| 21 October 2021
The document provides clarifications on the requirements and operating procedures for Notified Bodies, authorized by the Authorities responsible for notified bodies to carry out certification procedures for the purpose of CE marking of medical devices, pursuant to Regulation (EU) 2017/745, which allows their placing on the market, putting into service and free movement within the Community in the territory of the European Union. The update of the Questions and answer document mainly provides clarifications on the services offered by notified bodies in the phases that precede the actual certification process in different ways.
Medical devices, classification guidelines | 15 October 2021
The purpose of this document is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements along with the examples of the risk classes to be attributed to different medical devices in accordance with Annex VIII of Regulation (EU) 2017/745.
AUSTRALIA
Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia | 19 October 2021
The Australian Government supported working closely with healthcare facilities, state and territory health departments to find ways to increase rapid information sharing about medical device safety and effectiveness following the Senate Inquiry into “the Number of women in Australia who have had transvaginal mesh implants and related matters” which highlighted that the number, range, and complexity of medical devices will increase over time.
Submissions received: Proposed refinements to the requirements for medical device patient information materials | 18 October 2021
The TGA thanked respondents who provided a submission to the public consultation related to the implementation of the requirement for sponsors of implantable medical devices and provided patient information leaflets (PIL) and patient implant cards (PIC) about their medical device. The requirements commenced in late 2018, with a gradual implementation over three years. Guidance documents will be updated to address other concerns raised in the consultation, following a decision from the Government on the proposed refinements.
Essential Principles – consent for noncompliance | 14 October 2021
There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989, for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance. In circumstances preventing compliance to one or more parts of an Essential Principle for a limited period, sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle. For sponsors that are applying for consent to import, supply, or export medical devices that are non-compliant with EP13A, a specific form has been developed.
Classification of active medical devices (including software-based medical devices) | 11 October 2021
The guidance assists manufacturers of active medical devices, including software-based medical devices, to correctly classify their devices as classification rules are applied according to the manufacturer’s intended purpose and considering how the device works. Manufacturers must consider all the classification rules in classifying their medical device. Where more than one rule applies, the device must be classified at the highest applicable level.
Global Medical Device Nomenclature (GMDN) Terms | 06 October 2021
Global Medical Device Nomenclature (GMDN) Terms are an international naming and grouping convention used to identify and consistently describe medical devices. GMDN Terms are made up of a five (5)-digit numeric Code, a Term Name, and a Definition. Devices are taken to be of the same kind if they have the following characteristics: • the same Sponsor • the same Manufacturer • the same classification • the same GMDN Term • for Class III medical devices, Class AIMD medical devices and Class 4 IVD devices (other than an immunohematology reagent that is a Class 4 IVD medical device), the same unique product identifier (UPI)
The concept of a kind of medical device forms the basis of such things as • conformity assessment • applications for inclusion in the Australian Register of Therapeutic Goods (ARTG) • custom-made medical device notifications • registrations for transition • adverse event notifications
Regulation of software based medical devices | 11 October 2021
The purpose of the guidance is to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply. Manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia, and if necessary, to seek professional advice. It is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.
USA
CDRH Proposed Guidance Development | 26 October 2021
The Center for Devices and Radiological Health (CDRH) posts two lists of guidance documents each year that it intends to publish during the fiscal year along with an annual retrospective list of previously issued guidance’s for stakeholder review and input. These lists are: • The A-list: A list of prioritized guidance documents that the Agency intends to publish during the fiscal year. • The B-list: a list of guidance documents that the Agency intends to publish as resources permit during the fiscal year.
CDRH Proposed Guidance’s for Fiscal Year 2022 (FY2022) | 26 October 2021
The Center for Devices and Radiological Health (CDRH) posts two lists of guidance documents each year that it intends to publish during the fiscal year along with an annual retrospective list of previously issued guidance’s for stakeholder review and input. These lists are: • The A-list: A list of prioritized guidance documents that the Agency intends to publish during the fiscal year. • The B-list: a list of guidance documents that the Agency intends to publish as resources permit during the fiscal year.
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2022 Proposed Guidance Development | 27 October 2021
The Food and Drug Administration (FDA) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH) intends to publish in fiscal year (FY) 2022. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders.
Medical Device Reporting (MDR): How to Report Medical Device Problems| 20 October 2021
Medical Device Reporting (MDR) is one of the Post Market Surveillance (PMS) tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Mandatory reporters (manufacturers, device user facilities, and importers) and voluntary reporters (health care professionals, patients, caregivers, and consumers) are required to submit to the FDA certain types of reports for adverse events, product problems, use errors, product quality issues, and therapeutic failures about medical devices. For voluntary reporting, form FDA 3500 may be used by health professionals or consumers.
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | 20 October 2021
On 7 November 2013, The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”. This updated draft guidance, which supersedes the 7 November 2013 draft guidance, intend to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. This draft guidance is not final nor is it in effect currently.
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | 20 October 2021
The Food and Drug Administration (FDA) is proposing to establish a regulatory category for over the counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. FDA propose to: • define OTC hearing aids and establish applicable requirements • amend existing rules for consistency with a new OTC category • repeal the conditions for sale applicable to hearing aids • amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal pre-emption that would become obsolete because of changes to the hearing aid requirements
Surgical Staplers and Staples for Internal Use – Labeling Recommendations Aids | 08 October 2021
The Food and Drug Administration (FDA) is issued the guidance to provide labelling recommendations for surgical staplers and staples for internal use as malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This guidance would help promote the safe and effective use of surgical staplers and staples for internal use by helping manufacturers develop labelling with information about specific risks, limitations, and directions for use of the device.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations | 08 October 2021
This information collection supports implementation of medical device labelling requirements governed by section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in Agency regulations, and discussed in associated Agency guidance. Medical device labelling regulations in parts 800, 801, 809, and associated regulations in parts 660 and 1040 (21 CFR parts 660, 800, 801, 809, and 1040), prescribe the disclosure of specific information by manufacturers, importers, and distributors of medical devices about themselves and/or the devices, on the label or labelling for the devices, to health professionals and consumers.
Breast Implant Post Market Safety Information | 27 October 2021
FDA’s post market review of breast implant safety and effectiveness includes:
• Providing input and guidance to manufacturers as they work to meet post-approval study enrolment, follow-up, and objectives. • Communicating study status and findings to healthcare providers and patients to help inform them of risks associated with breast implants. • Evaluating breast implant Medical Device Reports (MDRs), especially those related to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and Systemic Symptoms in Women with Breast Implants. • Assessing all post market reporting requirements associated with the approved PMA, including manufacturing changes, design changes, and annual reports. When the FDA finds that a manufacturer has significantly violated the FDA’s regulations, the FDA notifies the manufacturer. This notification may be in the form of a Warning Letter.
Labeling for Approved Breast Implants | 27 October 2021
On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. The FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions and approved new labelling for all legally marketed breast implants that includes: • Boxed warning. • Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device. • Updated silicone gel-filled breast implant rupture screening recommendations. • Device description with a list of specific materials in the device. • Patient device card. The FDA expects manufacturers to post the updated device labelling to their websites within the next 30 days and has released updated information on the status of breast implant manufacturer post-approval studies.
FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants | 28 October 2021
The agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. • the agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions • the agency has approved new labelling for all legally marketed breast implants that includes a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device and a patient device card • the FDA released updated information on the status of breast implant manufacturer post-approval studies These actions will help patients understand the risks and benefits of breast implants and make more informed decisions about their health.
UK
UK, USA, and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software| 27 October 2021
The principles cover key elements of GMLP, for example: • having an in-depth understanding of a model’s intended integration into clinical workflow • the desired benefits and associated patient risks • selecting and maintaining training and datasets to be appropriately independent of each other These guidelines may be used to: • adopt good practices that have been proven in other sectors • tailor practices from other sectors so they are applicable to medical technology and the health care sector • create new practices specific for medical technology and the health care sector
Consultation on the future regulation of medical devices in the United Kingdom | 26 October 2021
Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices to enable: • Improved patient and public safety • Greater transparency of regulatory decision making and medical device information • Close alignment with international best practice • More flexible, responsive, and proportionate regulation of medical devices This consultation looks at how we might change the law around medical devices in the UK by updating the Medical Devices Regulations 2002 (as amended) (UK medical devices regulations). Two webinars aiming the industry and public were uploaded on the website.
Guidance: Borderlines with medical devices and other products in Great Britain | 01 October 2021
The guidance document covers borderline products with general medical devices as specified in Part II of the Medical Device Regulations 2002 (as amended) and does not cover borderlines with in-vitro diagnostic medical devices or active implantable medical devices.
SWITZERLAND
Patient care in Switzerland at risk| 17 October 2021
After getting the third country status, Switzerland continues exporting medical products under the new EU regulation but the current situation with imports is alarming. By implementing home-made import barriers, Switzerland is endangering the health care of its own population. Swiss MedTech is therefore urgently calling for changes to the national Medical Devices Ordinance.
PAKISTAN
Draft Guidelines for Imports & Exports of Therapeutic Goods (for Views/Comments of stakeholders) | 25 October 2021
The guidance document aim to provide an overview of the requirements, procedures and best practices for imports and exports in compliance with the legal and regulatory requirements for all therapeutic goods including finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials. The guidelines are meant to: • outline the requirements and documentation for import and export of therapeutic goods • determine the eligibility, who can import or export therapeutic goods • elaborate procedure adopted by DRAP for verification and port clearance • describe the responsibilities of the entities involved in import and export
KAZAKHSTAN
Kazakhstan has introduced the practice of inspection of medical devices before state registration| 18 October 2021
According to Yerken Dautbayev, Director General of NCELS, special attention is paid to the inspection of domestic manufacturers of medical devices, which should occupy a competitive niche and replace expensive imported medical products, provide domestic health care with high-quality medical products within the framework of the Government’s instructions. Since the beginning of this year, experts from the National Centre for Expertise of Medicines and Medical Devices have conducted inspections for domestic manufacturers of medical products and manufacturers of near and far abroad. The results of the inspection are an integral part of the registration dossier of medical products and are considered when forming the results of the examination.
BRAZIL
Deadline for loading instructions for use ends on 31 October | 04 October 2021
ANVISA informed about the deadline closure for the loading of instructions for the use of regularized medical devices on 31 October 2021 before the validity of The Collegiate Board Resolution (RDC) 431/2020. The standard states that companies holding records and notifications of these products must upload their instructions for use in the Medical Device Documentary Repository, available in the Regularized Product Consultations section of the Agency’s website and was in force since 1 November 2020. Companies holding records and notifications published or published after the validity of RDC 431/2020 have up to 30 days to arrange the loading of documents in the repository, after the regularization of the product with the Agency.
LITHUANIA
For the attention of companies manufacturing orthopedic medical devices | 28 October 2021
The State Accreditation Service for Health Activities under the Ministry of Health invites orthopaedic medical device manufacturers to free distance learning for the application of the new Regulation (EU) 2017/745 of the European Parliament and of the Council on the application of medical devices on 18 November 2021, 9.00 on MS Teams by mailing the name of the company or institution intending to participate in distance learning and name and contact details (e-mail, phone number) of the person who will participate in the distance learning on [email protected]
IMDRF DOCUMENTS
Competence and Training Requirements for Auditing Organizations | 20 October 2021
The document applies to recognized Auditing Organizations conducting audits of a medical device manufacturer for regulatory purposes. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of manufacturers by ensuring that Auditing Organization personnel have the necessary commitment, competence, experience, and training before conducting an audit or undertaking a decision-making function.
Regulatory Authority Assessor Competence and Training Requirements | 20 October 2021
The document applies to Regulatory Authorities conducting assessments of Auditing Organizations. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of Auditing Organizations by ensuring that Regulatory Authority personnel have the necessary competence and training before conducting an assessment or participating in a decision to recognize an Auditing Organization.
MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization | 20 October 2021
The purpose of the document is to explain the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from recognizing Regulatory Authorities assessment of an Auditing Organization and, to document the decision process for recognizing an Auditing Organization or cessation of recognition. This document defines: • The process and lifecycle for recognizing, maintaining, or ceasing recognition of an Auditing Organization. • The process of managing, grading, and closure of assessment nonconformities issued to an Auditing Organization • The outcomes of an initial, surveillance, or re-recognition assessment process of an Auditing Organization
The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September 2021
Regulations EU MDR 2017/745 on Medical Devices and EU IVDR 2017/746 on In Vitro Diagnostic Medical Devices contain important improvements among which stricter control for high-risk devices is implemented via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence and increased transparency. To this end, they require the establishment of scientific bodies, namely expert panels, expert laboratories, and EU Reference Laboratories (EURLs). Their roles, described in Article 106 of the MDR and Article 100 of the IVDR, are to provide the European Commission, Member States, notified bodies and manufactures with scientific and technical advice, contribute to guidance and other relevant documents, and to identify emerging issues of concern regarding medical devices and in vitro diagnostic medical devices.
Helsinki Procedure for borderline and classification under MDR & IVDR| September 2021
The document is an updated version of the system agreed at the Medical Device Competent Authorities Meeting in Helsinki in October 2002. The purpose of the system is: • to allow consultation among competent authorities (CAs) on borderline and classification issues concerning medical devices • to ensure that appropriate guidance is published in the Manual on Borderline & Classification for Medical Devices (hereafter referred to as the Manual) The system was revised following the entry into application of the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) by the Borderline & Classification Working Group (BCWG)1 of the Medical Devices Coordination Group (MDCG) in 2021.
AUSTRIA
New Regulation on the Administrative Fee Tariff | 21 September 2021
A new fee regulation of The Federal Office for Safety in Health Care (BASG) was put into force from 1 August 2021 for clinical investigations of medical devices as per the EU Regulation 2017/745. The fee reduction applies to performance evaluation reviews and amendment requests for studies according to the Medical Devices Act, BGBl. I No. 46/2021 (tariff point XII.1.a-b) but doesn’t apply for initial and amendment applications (tariff points XII.2.a-g) for commercial studies. Tariffs for academic clinical investigations of medical devices according to Regulation (EU) 2017/745 are not reduced.
BELGIUM
New version of Belgian directive for management of clinical trials during coronavirus pandemic | 02 September 2021
The available new version of the national directive is the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. These new guidelines should help sponsors of clinical trials to manage: • clinical trials for the prevention or treatment of COVID-19 • clinical trials underway in Belgium This directive also provides answers to frequently asked questions and will be updated depending on how the pandemic further develops.
FINLAND
Piloting of the EU Regulation on Clinical Trials ends in Finland | 17 September 2021
Finnish Medicines Agency (FIMEA) and the National Committee on Medical Research Ethics (TUKIJA) started the piloting of the new clinical trials assessment process in accordance with the EU Regulation in November 2020. Now the project has reached the final stage. The project has reached the final stage and 27 September 2021 is the deadline for submission of applications regarding new clinical trials and substantial modifications in the pilot project.
SLOVENIA
Procedure for entering a test intended for self-testing in the central database of medicinal products (CBZ) | 14 September 2021
With a question on the procedure for the entry of rapid tests determining the presence of SARS-CoV-2 antigen in the Central Database of Medicinal Products (CBZ), Public Agency for Medicinal Products and Medical Devices (JAZMP) mandated submission of following documents for the registration: • EC declaration of conformity showing that the test is for self-testing (risk class: IVD – self-testing, indicating the CE number of the certificate) • CE certificate of notified body established in the EU (with reference to Directive 98/79/EC or Regulation (EU) 2017/746) • Original package leaflet • Instructions for use in Slovenian (Translation must be the same as the original instruction with all indications) In accordance with the legislation in the field of medical devices, the business entity carrying out the marketing of the medical device or in vitro diagnostic medical device to the JAZMP must be properly registered.
MDCG guideline 2021-23 (Article 16 of EU regulation 2017/745) is installed by distributors, importers and notified bodies| 02 September 2021
The guidance intends to help notified bodies to implement requirements established by MDR and IVDR about certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. It also addresses distributors and importers in respect to their quality management system to be certified by a notified body.
ITALY
Guidelines for the certification of quality systems of importers and distributors operating in parallel trade | 14 September 2021
The guide aims to aid notified bodies under Regulations (EU) 2017/745 and 2017/746 regarding the certification activities of the quality management system of importers and distributors, who operate as re-packagers and re-labelers (parallel traders) pursuant to Art. 16 (2) of the two Regulations. This guidance also addresses distributors and importers in respect to their quality management system to be certified by a notified body.
SPAIN
Extension of the deadline for adaptation of labelling and instructions for use of medical devices as a result of the EU-Switzerland MRA | 16 September 2021
The Spanish Agency of Medicines and Medical Devices AEMPS extends the deadline until 30 September 2022 for the adequacy of the labelling and instructions for use of medical devices because of the status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices.
The AEMPS publishes the Spanish translation of the guide for manufacturers of class I medical devices | 02 September 2021
The translation of the document “MDCG 2019-15 rev.1 – Guide for manufacturers of class I medical devices” aims to help Spanish manufacturers of such devices to comply with the provisions of Regulation 2017/745 on medical devices and apply to situations where an importer, distributor or any other legal person assumes the obligations mandatory for manufacturers.
CZECH REPUBLIC
Q&A for labelling | 24 September 2021
The Rules Governing Medicinal Products in the European Union Volume 4 guideline highlights the requirements for labelling of Investigational medicinal products regarding which questions and answers are published.
The Rules Governing Medicinal Products in the European Union Volume 4 guideline highlights the requirements for labelling of Investigational medicinal products regarding which questions and answers are published.
IRELAND
Public consultation on proposed clinical trial fees for 2022 | 10 September 2021
A new Clinical Trial Regulation (CTR) (Regulation No 536/2014) was adopted on 16 April 2014 and becomes applicable on 31 January 2022. The CTR is designed to benefit patients and medical research in Europe by streamlining the approval of clinical trials across the Member States. The document provides details of the fees intended to be charged for clinical trial applications under the Clinical Trial Regulation (CTR), and background information.
New Clinical Trial Fees
Clinical Trial Fees
Substantial Modifications
Substantial Modifications
SWITZERLAND
Update: Obligations for authorized representatives, importers and distributors | 27 September 2021
The following timelines apply to manufacturers or authorized representative established in an EU/EEA state: • High-risk devices (Class III, IIb implantable and AIMD): 31 December 2021 • Moderate-risk devices (non-implantable Class IIb, Class IIa): 31 March 2022 • Low-risk devices (Class I): 31 July 2022 • Systems and procedure packs: 31 July 2022 EEA states are the member states of the EU, Iceland, Norway, and Liechtenstein but the timelines apply only to EU states, Norway and Iceland as Liechtenstein and Switzerland has the customs treaty between, due to which manufacturer in Liechtenstein is not obliged to designate an authorized representative in Switzerland.
All otherforeign manufacturers are required to appoint a Swiss Authorized Representative with effect from 26 May 2021 and the labelling is linked to the designation of the Authorized Representative. These provisions apply both to MDD / AIMDD and MDR devices.
Unique identification no. in accordance with Art. 55 MedDO (CHRN – Swiss Single Registration Number) | 27 September 2021
The Swiss Single Registration Number (CHRN) is a unique identification number that Swissmedic assigns to Swiss manufacturers, authorized representatives, and importers upon request to unambiguously identify a manufacturer, authorized representative, or importer. It is necessary for economic operators domiciled in Switzerland to register once with Swissmedic within three months of placing their first product on the Swiss market. This rule also applies to persons who assemble systems and treatment units in accordance with Art. 11 MedDO. Questions and Answers are published as the updates on Swissmedic website.
BAHRAIN
Phase 2 of Permit to use of Medical Devices | 05 August 2021
NHRA is initiating the second phase of the national program of permit to use based on circular dated 19/3/2018 regarding the National Registry of Medical Devices and the Resolution No. (48) of 2020 on Medical Devices and Products’ Quality Control, article (8) which includes providing the quality assurance certificates for the previously listed devices on Phase one of the program which reached the total of 21,631 medical devices by sending the required documents to the medical device’s regulation team mail. This project would be completed by the end of 2025 where all previously approved and registered medical device details will be uploaded on NHRA website.
Tracing of Implantable medical devices | 28 June 2021
As per the National Health Regulatory Authority (NHRA), written policies and procedures should be implemented to: • trace the implantable medical devices • take the necessary corrective action if needed • ensure the safety of patients from exposure to side or adverse effects which may be caused by the devices Following documents should be documented in a hardcopy or softcopy/software system format: • Patient’s name • CPR No. • Contact No. / e-mail address • Device Type • Device Serial No. • Manufacturer name and country of origin • Bahrain authorized representative
Change of the appointment booking program | 15 June 2021
NHRA informs all the importers about the changing of appointment booking program for Medical devices regulations services from Appointy program to Microsoft Bookings as additional services are included. The appointment registration process will have an effective role in facilitating the procedures. Point to note is that pre-booked appointments were not affected.
Transforming the regulation of software and artificial intelligence as a medical device | 16 September 2021
Applications of AI to be regulated as medical devices can range from screening to diagnosis, to treatment, and to management of chronic conditions. MHRA has developed an extensive work program to inform regulatory changes including key reforms across the software as a medical device lifecycle, from qualification to classification, to requirements that apply pre- and post-market considering challenges and opportunities posed by AI as a medical device, ensuring these devices are appropriately evidenced and address issues of human interpretability and adaptivity. MHRA received a grant of £194,000 from the Regulatory Pioneers Fund for carrying out further research into how adaptive AI algorithms in medical devices change and how to regulate their decisions.
MHRA launches public consultation on future of medical device regulation | 16 September 2021
10-week consultation launched by MHRA gives everyone the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework and therefore patient safety in the future. This consultation is comprehensive covering a broad range of regulatory issues from requirements for running clinical investigations, to how devices are assessed before being placed on the market through to importer and distributor obligations and post-market surveillance to transparency and the role of patients. The consultation is held here and it ends on 25 November 2021 at 11.45pm.
Long-term continual use of topical steroids linked to skin withdrawal side effects | 15 September 2021
Topical corticosteroids are medicines applied directly to the skin to treat conditions such as eczema or psoriasis. Patients can experience topical steroid withdrawal reactions after using these products at least daily for long periods of time. A severe type of topical steroid withdrawal reaction can occur, which may also be known as red skin syndrome or topical steroid addiction for which the Medicines and Healthcare products Regulatory Agency (MHRA) advises anyone experiencing skin redness or burning sensations after they have stopped using these creams or ointments to seek advice from their health professional before using these products again.
Updated guidance on Managing clinical trials during Coronavirus (COVID-19) | 08 September 2021
The guidance assists: • those involved in clinical trials disrupted because of COVID-19 • those involved with ongoing studies, wishing to restart trials that have been paused or temporarily halted • those wishing to start new studies
USA
Device Registration and Listing | 30 September 2021
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. Congress has authorized FDA to collect an annual establishment registration fee for device establishments. The establishment registration fee is not eligible for a reduced small business fee. The annual registration user fee for fiscal year 2022 follows:
YEAR
FY2022
FEE
$5,672
Electronic Submission Template for Medical Device 510(k) Submissions | 28 September 2021
This draft guidance document introduces submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA.
Good Clinical Practice (GCP) Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic (IVD) Device Premarket Submissions | 27 September 2021
The FDA has established human subject protection regulations addressing requirements for informed consent and Institutional Review Board (IRB) review that apply to all clinical investigations of devices involving human subjects, including deidentified human specimens.
Medical Device Material Safety Summaries: ECRI Reports | 22 September 2021
The U.S. Food and Drug Administration (FDA) partnered with Emergency Care Research Institute (ECRI), 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. 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. Currently available safety summaries are of: • Magnesium • Polypropylene (often used in surgical mesh) • Polyurethanes • Siloxanes (often used in breast implants)
Unique Device Identification System (UDI System) | 16 September 2021
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device post market surveillance, and facilitate medical device innovation.
BRAZIL
Import: pilot project makes migration to Single Portal of Foreign Trade | 20 September 2021
National Health Surveillance Agency (ANVISA) informed the regulated sector about the importation of advanced therapy products is now part of the petition pilot project through the application in the Module Licenses, Permits, Certificates and Other Documents (LPCO) import of the Single Portal of Foreign Trade. According to the publication, the Federal Revenue Service of Brazil (RFB) and the consenting agencies must migrate the import process to the Single Foreign Trade Portal, which should be used as a single window for users to make requests and hold on payments at all public agencies involved in the import process, such as ANVISA for products subject to sanitary surveillance. A step-by-step guide is available for companies in the regulated sector regarding the procedure.
ANVISA approves public consultation on import for scientific research | 15 September 2021
On 15 September 2021, the Collegiate Board of ANVISA approved the opening of a Public Consultation to update RDC 172/2017, which deals with the import of products and medicines for scientific or academic research. The objective is to improve sanitary control in the import of products used in scientific research with human beings and to curb the diversion of purpose for irregular consumption of these products.
Consolidation of standards did not change the merits of RDC 207/2018 | 02 September 2021
On 31 August 2021, ANVISA published the Board Resolution (RDC) 560/2021 standard for the organization of health surveillance actions related to the Operating Authorization, Licensing, Registration, Certification of Good Practices, Inspection, Inspection and Standardization, within the scope of the National Health Surveillance System – SNVS.
Standard updates requirements for producing male condoms | 01 September 2021
On 31 August 2021, the Resolution of the Collegiate Board (RDC) 554/2021 was published in the Official Gazette (D.O.U), which establishes the minimum requirements to produce male condoms of natural rubber latex. Topics covered are regarding the design and dimensions of the products, issues related to the expiration date of condoms, volumetric capacity, and pressure, as well as requirements for packaging and labeling, among other items. In addition to the requirements of RDC 554/2021, male natural rubber latex condoms must also meet compliance certification requirements under the Brazilian Conformity Assessment System (SBAC).
CANADA
Regulations amending certain regulations concerning drugs and medical devices (shortages) | 01 September 2021
On 11 August 2021, the Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made, amending the Food and Drug Regulations and Medical Devices Regulations, and were published in Canada Gazette, Part II on September 1st, 2021. These new regulations extend and modify certain measures already in place through 2 interim orders (IOs). They have been made to help track, prevent, and mitigate shortages of key health products in Canada, including drugs and medical devices.
AUSTRALIA
Export of therapeutic goods from Australia | 25 September 2021
To export therapeutic goods from Australia, you must meet requirements set out in the therapeutic goods legislation, in addition to other Commonwealth and State or Territory legislation. Export regulation supports the development and manufacture of Australian therapeutic goods and ensures that goods leaving Australia meet appropriate safety and quality standards to support public health. Medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs) must be included in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless they are the subject of an exemption or exclusion. To facilitate export, the TGA issues export certification for medical devices that are included in the ARTG under section 58 of the Therapeutic Goods Act 1989. If certification is required by the importing country, the TGA can issue a Certificate of Free Sale or Export Certificate.
Reclassification of spinal implantable medical devices | 22 September 2021
The purpose of the provided guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements. From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include: • more detailed assessment of the manufacturer’s quality management systems and technical documentation related to each device • conformity assessment documents demonstrating procedures appropriate for their classification • a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence
Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems | 22 September 2021
The provided guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations. From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.
The requirements include: • more detailed assessment of the manufacturer’s quality management systems and technical documentation related to each device • conformity assessment documents demonstrating procedures appropriate for a Class III device • mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence
Software for use with COVID-19 rapid antigen self-tests | 20 September 2021
The guidance includes information about the Therapeutic Goods Administration’s (TGA) requirements for software and apps designed for use with COVID-19 rapid antigen self-tests. Purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s expectations concerning software or apps for use with COVID-19 rapid antigen self-tests that are intended to analyse and enable the interpretation of the test results. COVID-19 rapid antigen self-tests are tests that allow individuals to collect a specimen, conduct a test and interpret the results by themselves. These tests can be performed in the home, without the involvement of a health professional and are most accurate when used in a symptomatic person within the first few days of showing symptoms.
Conformity assessment certificates, changes to requirements for certain medical devices | 17 September 2021
On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2020. From 28 July 2021, medical devices that contain medicines or materials of animal, microbial, recombinant, or human origin and Class 4 in vitro diagnostic (IVD) medical devices no longer require mandatory TGA conformity assessment certification. Australia has some different regulatory requirements to Europe (e.g.: biologicals) and therefore, the amendment to Regulation 5.3 provides the TGA to audit applications to ensure the information provided meets the Australian regulatory requirements. This ensures that safety and performance is demonstrated prior to approving the device for supply in Australia.
Essential principles checklist (medical devices) | 15 September 2021
Manufacturers are responsible to demonstrate compliance with the essential principles for their medical devices. Access to checklist
SINGAPORE
Cybersecurity vulnerabilities (BRAKTOOTH) affecting medical devices utilizing Bluetooth Classic | 01 September 2021
A recently discovered suite of cybersecurity vulnerabilities called “BrakTooth” are affecting various IOT devices, including medical devices that utilize specific Bluetooth Link Manager Protocols. If a medical device is affected by any of these vulnerabilities, it may allow an attacker in the radio range to trigger deadlocks, crashes or execute arbitrary code, which will lead to failure of critical device functions. To address these vulnerabilities, security patches developed by the respective Bluetooth chip developers, will have to be applied to the affected devices. Industry Stakeholders are required to work with manufacturers to carry out the following: • Identify the medical devices affected by the vulnerabilities • Report to HSA at [email protected] once identified affected medical devices • Perform a risk assessment of the vulnerabilities and the impact in the context of medical devices with reference to their intended use • Develop risk mitigation plans, including interim work-around (e.g. segregation controls) to manage the risk until they can be patched • Ensure that the necessary security patches are rolled out to all affected devices locally in a timely manner • Communicate with the healthcare institutions and the end users of the medical devices proactively and recommend necessary actions to reduce the risk and potential harm to the patients and users.
RUSSIA
Information about the medical organization and employed medical workers in the relevant Federal Registers. | 01 September 2021
From 1 September 2021, the Decree of the Government of the Russian Federation dated 01.06.2021 No. 852 came into force, establishing licensing requirements for the implementation of medical activities. This decree includes new requirements for the license applicant to place in the Unified State Information System. in the field of health care information about a medical organization in the Federal Register of Medical Organizations and about medical workers in the Federal Register of Medical Workers.
INDIA
Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices | 21 September 2021
The document highlights list of details and documents required for registration of medical devices by the Manufacturers and Importers along with steps to be followed by the manufacturers/ importers for registration of non-notified medical devices. • The registration of Class A, B, C & D devices has been kept voluntary for a period of 18 months with effect from 1 April 2020 i.e. till 30 September 2021 • Voluntary Registration of Class A & B devices shall be followed by mandatory registration for 12 months after 18 months of voluntary registration period is over i.e. up to 30 September 2022 • From 01 October 2022 Class A & B devices will fall under licensing regime. • Voluntary Registration of Class C & D devices shall be followed by mandatory registration for 24 months after 18 months’ Voluntary registration period is over i.e. 01 October 2021 to 30 September 2023 • From 01 October 2023 Class C & D devices will fall under licensing regime
PAKISTAN
Conduct of clinical trials guidelines (v2.0) | 02 September 2021
The guideline, drawn in conformity with the legal requirements of the Bio-Study Rules 2017, Drug Act 1976 and DRAP Act, 2012 and the rules framed under, describes the requirements, procedure for submission, review, evaluation, and approval of applications for the conduct of clinical trial. It is required that all the therapeutic goods and health products used in Pakistan are registered with the Drug Regulatory Authority of Pakistan (DRAP) and any clinical trial using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose. The guidelines set out the procedures that should be followed by applicants who wish to conduct clinical trials in Pakistan and the steps that DRAP will take to review, evaluate, and permit the conduct of such trials.
INTERNATIONAL STANDARDS
BS EN ISO 13485:2016: 2021 Amendments| 09 September 2021
EN ISO 13485:2016+A11:2021, was published by the European standards bodies, CEN and CENELEC featuring new annexes ZA and ZB that link the requirements of the MDR and IVDR, respectively, to specific clauses of the standard.
IMDRF DOCUMENTS
Assessment and decision process for the recognition of conformity assessment body conducting medical device regulatory reviews | 24 June 2021
The document intends to: • improve the efficiency and effectiveness of the review process for marketing of medical devices • explain the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from a recognizing Regulatory Authority’s assessment of a CAB • document the decision process for recognizing a CAB or cessation of recognition
The document defines: • the process and lifecycle for recognizing, maintaining, or ceasing recognition of a CAB • the process of managing, grading, and closure of assessment nonconformities issued to a CAB • the outcomes of an initial, surveillance, or re-recognition assessment of a CAB
Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.”
The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III).
For imported devices, the CH-REP should be indicated according to the below table:
Device Class
CH-REP Symbol / Indication to be placed on
Class I MDR Device
With effect from 26 May 2021 Until 31-Jul-2023Where: Either on the label (or) On the Document accompanying the device After 31-Jul-2023Where: On the label
Class IIa, IIb, III MDR Devices
With effect from 26 May 2021 Where: On the label
MDD/AIMDD Devices with EU/EEA manufacturer or EC-REP
With effect from 26 May 2021 Where:MDD – On label (or) Instructions for Use (or) In Document accompanying the device AIMDD – On sales packaging (and) Instructions for Use (or) In Document accompanying the device
MDD/AIMDD Devices without EU/EEA manufacturer or EC-REP
With effect from 26 May 2021 Where:MDD – On label (or) Instructions for Use AIMDD – On sales packaging (and) Instructions for Use
“CH-REP” Symbol
Representation / Usage of the “CH-REP” Symbol on the Device packaging
The name of the Swiss AR must be available on the product label.
The Name and Address of the Authorised Representative (AR) must appear adjacent to the symbol.
The mentioned Address must enable provision to contact the Swiss AR with sufficient contact details.
The symbol’s size and name are not defined; however, they must be adequately visible to the naked eye.
Symbols to Use
Where symbols are used, they must confirm to the harmonised standards. Swiss medic rule allows the sole use of the symbol without any description of the symbol explained in the product documentation enclosed.
Other CH-REP Representation(s)
Instead of the symbol, Swiss medic also permits the indication as stated below:
“CH-Authorised Representative”
“CH-REP”
“Authorised Representative for Switzerland”
Rules for Manufacturers from EU/EEA
Manufacturers placed in the EU/EEA also fall under this obligation to appoint their Swiss AR (called CH-REP or Swiss Rep or SAR). It is least expected that a single CH-REP is appointed for devices that belong to the same medical device group or family.
What does “In a document accompanying the device” mean and where should I make this information available?
This information can be affixed to the device or be available separate from the device. Available separate refers to documents such as delivery notes, customs documents, guarantee certificates, invoices, a sticker on the packaging or the instructions for use.
Such documents are made available with the device throughout the supply chain route. It is available until it reaches the distributors and need not be necessarily available to the end customer. Note that this accompanying interpretation differs from the Swiss with EU MDR.
Is the definition of a “document accompanying the device” of Swiss MedDO and Europe’s MDR 2017/745 the same?
No, they are not the same. The interpretation of document accompanying the device definition differs from Swiss MedDO and EU MDR.
In what languages must the medical device product information such as Labelling and Instructions for Use be written for the Swiss market?
It must be written and made available in all three official languages of Switzerland (German, French and Italian). Symbols established by using technical standards may be used to replace the written statements.
What are the other obligations of a Swiss AR / CH-REP?
A detailed obligation/responsibilities of a CH-REP are available in our article Obligations of the Swiss Authorised Representative.
Who are the Economic Operators required to be registered with Swiss medic?
Manufacturers (or) their Swiss Authorised Representative must register themselves within three months of placing the device for the first time in the Swiss market.
During registration, they must cater information as per Part A of Annex VI EU MDR 2017/745. Further obligations and registration modalities are governed by Article 30 and Article 31 of EU MDR 2017/745
