EUROPEAN UNION (EU)
Notified Bodies Position paper on application of hybrid audits for QMS assessments under MDR and IVDR|26 September 2022
The latest position paper discusses the need for hybrid audits instead of the traditional on-site audits which were previously followed. The document represents the collective position on aspects to be considered while employing Information and Communication Technologies (ICT)-based auditing for quality management systems.
Manual on borderline medical devices and classification under MDR and IVDR |24 September 2022
This latest manual describes various borderline products such as nasal sprays, cosmetics, biocides, and even personal protective equipment. Following Regulations (EU) 2017/745 on Medical Devices (the MDR) and (EU) 2017/746 on In Vitro Diagnostic Medical Devices, this document details the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following exchanges under the Helsinki Procedure (the IVDR).
The document covers certain borderline products and the applicable regulations for making these products available on the market.
MDCG guidance on first certification of that type of device and procedure to be followed by Notified bodies|14 September 2022
The latest Medical Device Coordination Group (MDCG) guidance describes “ the first certification for that type of device”. For Class D devices, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices, certain conditions when the notified body must approach an expert panel are established. These conditions are:
- The absence of common specifications for the class D device, and
- where it is also the first certification for that type of device.
MDGC guidance on surveillance regarding the transitional provisions under Article 110 of the IVDR| 14 September 2022
The MDCG guidance document 2022-15 describes the activities that notified bodies must carry out as part of the appropriate surveillance as described in Article 110(3) last subparagraph IVDR. This guidance document also addresses certain manufacturers’ obligations, particularly regarding their quality management system, to clarify elements to be verified by notified bodies.
FIMEA update on distributor notification | 28 September 2022
According to Section 49 of the Medical Devices Act (719/2021), an operator that distributes devices to retailers, health care and social welfare operators, and other professional users, as well as other users, must notify the Finnish Medicines Agency of its operations and devices. Device notifications must be submitted by 30 November 2022.
Fimea has decided that these distributors will not be required to submit device notifications this year due to the large number of devices that need to be notified and the difficulty in keeping device notifications current. In 2023, the fee charged for distributor notification will be EUR 500.
HPRA Invites Clinical Experts to Join Expert panel | 23 September 2022
The HPRA is requesting clinical specialists to indicate their interest in joining a new external expert panel to contribute to the regulatory examination and assessment of medicines and medical devices. The HPRA continues to protect public health by working closely with outside clinical specialists, such as physicians, pharmacists, and other healthcare professionals.
Applications to market novel medicines that offer patients new treatment options, any emerging quality or safety concerns regarding medicines and medical devices on the market, clinical input for clinical studies and scientific advice for new products under development may all call for external experts.
Extension of the simplified registration procedure of medical devices until 2025| 23 September 2022
The Federal Service for Surveillance in Health Care informs that Decree of the Government of the Russian Federation dated September 19, 2022 No. 1643 amended the Decree of the Government of the Russian Federation dated April 1, 2022 No. 552 “On approval of the specifics of circulation, including the specifics of state registration, of medical devices in the event of their defect or the risk of a defect in connection with the introduction of restrictive economic measures against the Russian Federation”, including in terms of extending the validity of this regulatory legal act until January 1, 2025.
The validity of medical device registration certificates issued before the Government of the Russian Federation Decree effective date of September 19, 2022, No. 1643, with a fixed expiration date of September 1, 2023, is scheduled to continue until January 1, 2025, without replacement.
Application for conduct clinical trials permit (research)| 06 September 2022
A permit must be obtained to conduct clinical trials (research) of medical devices within the Eurasian Economic Union framework. The Federal Service for Surveillance in Healthcare informs about the placement of an electronic form on the “Unified Portal of State and Municipal Services (Functions)”. To apply, the portal of public services must be used.
UNITED KINGDOM (UK)
MHRA appoints first the new UK Approved Body to certify medical devices since Brexit| 29 September 2022
To ensure that only safe and effective medical devices are distributed to UK consumers, the Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd. has joined the three other UK Approved Bodies.
Any potential organisation must go through the new designation process to be approved to certify medical devices in the UK, and DEKRA has become the first organisation to complete it. They are now recognised as a body authorised by the UK to conduct evaluations of general medical devices. The list of approved bodies in UK can be accessed here.
Updated Swissmedic forms for medical devices and in vitro devices| 26 September 2022
The following Swissmedic forms have been updated in September:
- Export certificates for medical devices form
- Form for export certificates for medical devices subject to old legislation, DEVIT products and IVDs
- Form for authorisation clinical investigation for medical devices
- Form for Clinical investigation of research sequences on CE-marked MRI systems
- Form for simplified review of clinical investigation of medical devices
- Form for notification, amendment of clinical investigation of medical devices
- Notification form of safety measures for clinical trials
- Forms for serious adverse event (SAE) and device deficiency for medical device and in vitro diagnostics
Swissdamed- Swiss database for medical devices| 13 September 2022
Since the agreement on the mutual recognition of conformity assessments (MRA) between the Swiss Confederation and the European Union has not been updated, Swissmedic is responsible for registering economic operators (CHRN), medical devices, and in vitro diagnostic medical devices (product identification, UDI).
Swissmedic began implementation of the “Swissdamed” database in April 2022. Swiss Database on Medical Devices is known as Swissdamed. Swissdamed comprises two linked modules and a public website. It will also register economic operators in addition to medical devices.
Swissdamed will be rolled out in three releases. The first release will cover the registration of economic operators. Medical device registration will be possible after the second release. Swissmedic intends to involve selected economic operators in the realisation phase. The third release will introduce additional functions in the modules already implemented.
Event on regulations for in vitro diagnostic medical devices | 05 September 2022
The amendment to the Ordinance on Clinical Trials with Medical Devices and the new Ordinance on In Vitro Diagnostic Medical Devices (IvDO) were both approved by the Federal Council on May 4, 2022. (CTO-MedD). On May 26, 2022, the new legal requirements went into effect along with the EU’s implementation of the IVDR. Clinical studies involving in vitro diagnostic medical devices have been governed by the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) since May 26, 2022, and no longer (ClinO).
The event is primarily intended for people, businesses, and organisations based in Switzerland that produce, market, and utilise in-vitro diagnostic medical devices (IVD) and people assigned specific tasks by manufacturers based overseas. The event is set to happen on 03 November 2022.
Information sheet on Swiss single registration number (CHRN) | 30 August 2022
The latest Swissmedic information sheet on the Swiss single registration number (CHRN) contains information on the application procedure of CHRN by economic operators domiciled within Switzerland. The document also contains vital information on the obligations of operators, the payable fees and the processing time for a CHRN request.
It is essential for manufacturers placed outside Switzerland to appoint an Authorised Representative (AR) before the upcoming deadlines mentioned below.
For IVDD and IVDR devices:
|Class of device||Deadline|
|Class D||31 December 2022|
|Class B and C||31 March 2023|
|Class A||31 July 2023|
UNITED STATES OF AMERICA (USA)
FDA Guidance on Monkeypox Tests| 26 September 2022
Monkeypox virus diagnostic tests are used to establish whether a person is infected with the Orthopoxvirus, a type of virus that causes monkeypox.
The Centers for Disease Control and Prevention (CDC) offers a real-time polymerase chain reaction (PCR) test that has received FDA clearance for detecting DNA from non-variola orthopoxviruses, such as monkeypox virus: CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set. There are designated CDC Laboratory Response Network (LRN) and other CDC-designated laboratories that offer the CDC test. For the non-variola Orthopoxvirus or specifically for monkeypox, laboratory-developed tests (LDTs) might also be accessible. An LDT is a specific kind of in vitro diagnostic test created, used, and maintained within a single CLIA-certified laboratory and complies with high complexity testing standards.
FDA Guidance on Electronic Submission Template 510(k) submissions | 22 September 2022
The guidance titled “Electronic Submission Template for Medical Device 510(k) Submissions” is now available, according to the Food and Drug Administration (FDA or Agency). The FDA is releasing this draft guidance to inform submitters of premarket notification (510(k)) about the resources and related content currently available to support 510(k) electronic submissions to FDA.
The electronic submission template, eSTAR, is the only currently available electronic submission template at this time to facilitate the preparation of 510(k) electronic submissions. eSTAR consists of a collection of questions, text, logic, and prompts within a template that guides a user through constructing a ‘complete’ 510(k)18 submission. The complete document can be accessed here.
FDA Guidance on eCopy Program | 23 September 2022
A compact disc (CD), digital video disc (DVD), or flash drive is used to produce and submit an electronic copy (eCopy) of your medical device submission. A paper copy of the signed cover letter is enclosed with the electronic copy. An eCopy is required for the following submission types:
- Premarket notification submissions (510(k)s), including third party 510(k)s
- Evaluation of automatic class III designation petitions (de Novos)
- Premarket approval applications (PMAs), including Transitional PMAs; o This includes all PMA submission types, including, but not limited to, original PMAs, panel-track supplements, 180-day supplements, manufacturing site change supplements, 30-Day Notices, 135-Day Supplements, and post-approval study supplements and reports, as well as amendments involving changes in the correspondent or ownership and requests for extensions
- Modular Premarket approval applications (PMAs)
- Product development protocols (PDPs)
- Investigational device exemption (IDE) submissions
The guidance explains the procedure for submission of eCopy, how the FDA processes it and the FDA timelines for review of electronic submission.
Submission of Administrative documents through the SEI system| 22 September 2022
Anvisa notifies that starting on December 1st, all administrative papers submitted to the Agency must be handled electronically using the SEI petition. Corporate emails will no longer receive documents.
With enhanced transparency and institutional security, the orientation intends to expedite the treatment of requests and prevent duplication in processing papers. Unlike the electronic mail system, photoionisation channels offer tracking capabilities and ensure the delivery and reception of documents.
Anvisa approves the registration of the first test for the diagnosis of monkeypox in Brazil| 20 September 2022
ANVISA authorised the first product for the diagnosis of monkeypox in Brazil on September 20, 2022.
The Molecular Multiplex Kit OPXV/MPXV/VZV/RP Bio-Manguinhos is the Agency registered product. It is a product made by Fundaço Oswaldo Cruz employing a multiplex test to identify the genomic areas of the varicella-zoster, monkeypox, and orthopox viruses as well as to carry out an internal control (IC) using a human constitutive gene. the RNAseP (RP).
Clinical performance and risk management, which guarantee that the product is appropriate for the suggested use, were among the technical conditions examined by Anvisa to issue the registration. These requirements were included in Resolution (RDC) 36/2015. The examination found that the product satisfied the Agency’s technical requirements.
Anvisa updates rules for the regularisation of medical devices in Brazil| 14 September 2022
The updated text encourages the incorporation of Mercosur Resolution GMC No. 25/2021, which updated regional documentation standards and medical device categorisation guidelines at Brazil’s suggestion. In addition to internalising the standard, the document also compiles several other Anvisa laws on the regularisation of medical equipment.
Highlights of the new text are:
- Adoption of specific classification rules for new technologies, such as Software as Medical Device and nanomaterials
- Consolidation of notification, registration and change rules in a single RDC
- Incorporation of rules for the Documentary Repository of Medical Devices
- Incorporation of rules on Instructions for Use in non-printed format
- Adoption of the Table of Contents structure (IMDRF’s Table of Contents) for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions (regulatory convergence)
- Forecasting situations for stock depletion of finished products, packaging, labels, and instructions for use
- Formalisation of the procedural reassessment procedure and
- General modernisation of the text and updating of terminology.
The new RDC will go into effect on March 1, 2023, giving the productive sector time to amend any future applications it submits to Anvisa.
To spread awareness and prepare the industry for the new laws, seminars will be held both in-person and online for firms requesting notifications and registrations of medical devices in the second half of 2022.
Guidance document on borderline medical devices| 04 August 2022
This guidance document outlines the procedure for applicants’ requests for product designation and gives applicants advice on borderline products. It reflects the South African Health Products Regulatory Authority’s (SAHPRA) current thinking regarding medical devices and medicines’ performance, quality, and efficacy. The document is published for public comment, which closes by 08 November 2022.
Guidance on licensing for the establishment of medical devices | 23 September 2022
Medical Device Authority (MDA) has issued guidance on licencing medical devices. The document gives an insight into the requirements of the Quality Management Systems (QMS), Post Market (PM) responsibilities, types of licenses provided by MDA and other important information regarding the registration of medical devices in Malaysia.
Guidance on re-registration of medical devices |15 September 2022
A medical device must be registered under Malaysia’s Medical Device Act 2012 (Act 737) before it can be imported, exported, or sold. Therefore, a medical device registration application must be submitted in compliance with Act 737 requirements and a manner decided by the Authority in Medical Device Regulations 2012 (MDR).
Medical device registration is valid for five years. After the term, the registration holder must apply for the medical device’s re-registration before it may be kept in the market or imported or exported. The guidance contains crucial information on the re-application stages, application for conformity assessment and registration fees.
Guidance document on harmonised borderline products |05 September 2022
The latest Medical Device Authority (MDA) guidance on harmonised borderline products in ASEAN contains a list of Harmonised borderline products following the definition of medical device and agreed upon by the ASEAN Medical Device Committee (AMDC). The list contains borderline products such as Micropipettes, disinfectants for dental purposes, EDTA solutions and their classification as medical devices depending on the product usage.
Guidance document on the harmonised classification of medical devices in ASEAN|05 September 2022
Based on the manufacturer’s intended use/purpose, this guidance document provides a standardised list of risk classifications for medical devices, including in-vitro diagnostic (IVD) devices.
HSA update on potential oximeter inaccuracy | 16 September2022
The Health Sciences Authority (HSA) wants to warn consumers that people with a dark complexion may experience erroneous blood oxygen saturation readings from oximeters. Oximeter readings for these people typically show blood oxygen saturation levels greater than they are.
Oximeters are often positioned on the fingertips to calculate the percentage of blood oxygen saturation levels. To determine blood’s oxygen saturation, they use light to shine on it and measure the amount of light absorbed. Melanin, a skin pigment that may absorb both blood and the light from oximeters, is more prevalent in people with darker skin. Because of this enhanced light absorption, the oximeters may show these people’s oxygen saturation levels that are higher than they are.
Notification on Class A medical devices licensing regime| 20 September 2022
The Medical Devices Rules (MDR), 2017, have been the subject of draft amendment rules from the ministry of health and family welfare (MoHFW), which include clauses stating the registration requirement of Class A devices under the identified online portal. As per the draft notification, registration of the devices now require the following details along with name of site and medical device details:
- An undertaking stating the proposed device is Class A Medical Device (non-sterile and/or non-measuring)
- Manufacturer shall self-certify that product conforms to Essential principles checklist of safety and performance of such devices.
- The manufacturer shall self-certify to comply with the standards prescribed
- Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic
Guidance on Classification of non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments | 09 September 2022
In the latest notification, Central Drugs Standard Control Organisation (CDSCO) has issued a classification of surgical Instruments for general use intended to be used in various general surgical procedures. Under this document, the following surgical devices are classified as Class A medical devices:
- Cutting and Dissecting Surgical instruments
- Clamping and Occluding Surgical instruments
- Clamping and Occluding Surgical instruments
- Grasping and Holding Surgical instruments
SCPN Development to Upload Ingredients List- the United Kingdom| 09 September 2022
The OPSS, the UK’s competent authority for cosmetic products, delivered a message to registered SCPN users on September 5, 2022. Changes to the procedures for submitting alerts for cosmetic products were described in the communication.
An “enter ingredient information page” will take the place of the option to upload an ingredient-containing PDF. Users can add ingredients individually in precise or range concentrations using a new capability that takes inspiration from the EU Glossary of Cosmetic Substances. This will not impact the present frame formulation option, and businesses should continue to choose it as their preferred choice.
The revision will be put into effect on October 3, 2022. The OPSS has cautioned that this modification will remove PDFs from any notifications already in the draft form, necessitating a resubmission of the notification following the modified procedure. OPSS advises businesses to finish and submit draft notifications by September 30, 2022, and to delete any draft notifications that are no longer necessary to avoid any duplication.
UK Responsible Person Labelling Deadline Extension- the United Kingdom| 05 September 2022
The UK Responsible Person (RP) must be listed on cosmetic product labels for them to be sold in Great Britain (GB), according to information provided to CTPA by the Office for Product Safety and Standards (OPSS).
The UK Cosmetics Regulation went into effect in December 2020. A two-year grace period was set to end on December 31, 2022, at which point all goods sold in the United Kingdom would have had to comply fully with the UK Cosmetic Regulation or be removed from the market.
After carefully considering the need to list the UK RP on the product label, OPSS has decided to prolong this transitory arrangement for five years, or until December 31, 2025. Before this date, when the criteria of Article 19(1)(a) of the EU Cosmetic Products Regulation are met, the name and address of the responsible person and the country-of-origin requirements are satisfied (EU CPR). This does not account for compliance with non-EU regulations and does not relieve businesses from having to abide by the UK Cosmetics Regulation’s other requirements, such as notice and ingredient compliance. Companies are urged to make the final product label revisions during this extra period.
UK Government Release Updated Consolidated Cosmetic Regulation Online- United Kingdom| 01 September 2022
The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 were introduced into Parliamentary proceedings by the Office for Product Safety and Standards (OPSS) on October 13, 2020. The UK Cosmetics Regulation is based on Schedule 34 of this Statutory Instrument (SI).
The UK Cosmetics Regulation (UKCR) official consolidated version is now available on legislation.gov.uk. The consolidated version considers the adjustments required to apply Great Britain (GB) market to the EU Cosmetic Products Regulation (EU CPR).
Any modifications that become effective before 31 August 2021, including any changes to the component Annexes, are considered in the current official UKCR consolidated version.
Ukraine Government postpones new Technical Regulation on Cosmetics- Ukraine| 23 September 2022
The Ukrainian government delayed the Technical Regulations on Cosmetic Products (the UA Cosmetics Regulation), which were supposed to go into effect on August 3, 2022, have been delayed to August 3, 2024, due to martial law.
Additionally, until 3 August 2026, the modification will allow the commercialisation of cosmetics that are not consistent with the UA Cosmetics Regulation. For comparison, the new UA Cosmetics Legislation includes 1,641 chemicals that are forbidden from use in cosmetics, whereas the previous regulation only listed 412. UA Cosmetics Regulation’s overarching goal is to bring Ukrainian law into compliance with EU Regulation No. 1223/2009 of the European Parliament and Council on cosmetic goods. It establishes a new regulatory framework for cosmetics, and the industry and the government must prepare for its implementation.
Application form for Saudi Free sale certificate for cosmetics- Saudi Arabia|19 September 2022
Saudi Food and Drug Authority (SFDA) has published an application form to issue a Saudi Free Sale Certificate for cosmetic products. The form must be filled out and submitted electronically to the Department of Registration of Medicines and Beauty Products via the email [email protected]. The form must be along with a fee of 200 riyals per product. The fee is subject to vary according to the product.
Anvisa approves new rules for labelling personal hygiene products, cosmetics and perfume- Brazil|14 September 2022
The Resolution of the Collegiate Board of Directors about the definition, classification, technical requirements for labelling and packaging, microbiological control criteria, and the technical processes for the regularisation of personal care goods, cosmetics, and fragrances was adopted.
By requiring mandatory minimum standards for labelling personal hygiene products, cosmetics, and perfumes to be applied by the regulatory authorities of the countries in the region, updating technical requirements following the harmonisation of Mercosur rules is a measure of regulatory convergence. It helps to reduce information asymmetry and risks associated with the inappropriate use of these products.
In this view, the goal of the regulation that the Agency authorised is to guarantee that consumers have access to accurate and up-to-date information on the features of the goods, their safety, usage, and efficacy. The RDC extends the deadline for labelling adequacy for products that have previously been regularised at Anvisa until the effective date of this Resolution until 10/03/2025. Likewise, requests for registration or labelling amendments submitted before this Resolution went into effect or that Anvisa was already analysing will be examined in line with the resolutions in place at the time of the procedure.
Published ISO Standards for September 2022
List of Published ISO standards for medical devices and in-vitro diagnostic devices
- BS EN ISO 8536-3:2009+A1:2022 Infusion equipment for medical use. Aluminium caps for infusion bottles
- BS EN 60731:2012+A1:2022 Medical electrical equipment. Dosimeters with ionisation chambers as used in radiotherapy
- BS EN ISO 23368:2022 Anaesthetic and respiratory equipment. Low-flow nasal cannulae for oxygen therapy
- BS EN IEC 62127-1:2022 Ultrasonics. Hydrophones. Measurement and characterisation of medical ultrasonic fields
- ISO/FDIS 15189 Medical laboratories — Requirements for quality and competence
List of Published ISO standards for cosmetics
- ISO 11930:2019+A1:2022 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product — Amendment 1
- ISO 16128- 2:2017+A1:2022 Cosmetics — Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients — Part 2: Criteria for ingredients and products — Amendment 1
- ISO 16212:2017+A1:2022 Cosmetics — Microbiology — Enumeration of yeast and mould — Amendment 1
- ISO 18415:2017 +A1:2022 Cosmetics — Microbiology — Detection of specified and non-specified microorganisms — Amendment 1
- ISO 21149:2017+A1:2022 Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria — Amendment 1
- ISO 21150:2015+A1:2022 Cosmetics — Microbiology — Detection of Escherichia coli — Amendment 1
- ISO 22717:2015 +A1:2022 Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa — Amendment 1
- ISO 22718:2015 +A1:2022Cosmetics — Microbiology — Detection of Staphylococcus aureus — Amendment 1
- ISO 23674:2022 Cosmetics — Analytical methods — Direct determination of traces of mercury in cosmetics by thermal decomposition and atomic absorption spectrometry (mercury analyser)
- ISO 23821:2022 Cosmetics — Analytical methods — Determination of traces of mercury in cosmetics by atomic absorbtion spectrometry (AAS) cold vapour technology after pressure digestion
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.