Medical Devices | Summer Recap 2020
Measures relating to the fight against the spread of COVID-19
Recently, the French authorities published several articles relating to masks in response to the COVID-19 pandemic. The publications are:
- Supervision of prices for surgical-type masks and surveys of masks for the general public
- French Customs publishes guide to facilitate the importation of masks
- Government announces order for more than 1 billion sanitary masks made in France
- Sale of general public and surgical masks in pharmacies
On other hand, the ANSM (Agence nationale de sécurité du médicaent et des produits de santé) published the following framework sheet in relation to 3D printing:
Recently, French authorities published several articles in relation to masks used in response to the COVID-19 pandemic. The publications include:
- Different types of masks - FAQ
- Coronavirus information
- First step in DGCCRF checks to guarantee quality and accessibility of protective masks
- Sale of general and surgical masks in pharmacies
- The first step towards DGCCRF checks to guarantee the quality and accessibility of protective masks
Other articles related to COVID-19:
Guidance in relation to mask and protective clothing manufacturing.
The Ministry of Industry, Commerce and Tourism has published new documents in relation to masks and protective clothing. Please see below a list of recent publications:
Overview:
- Clarification of the different types of PPE and Health Products
- >What mask do I need depending on my situation
- List of all standards applicable to PPE and Medical Devices
Surgical masks:
- Medical product type masks s; also known as surgical masks
- Manufacturing process required to deem surgical masks as Medical Devices
Marketplace Spain Chamber:
- Presentation-Summary - CE marking of EPI and PS products
Publications by the European Commission
Over the last number of months, the European Commission has published a variety of documentation, information and publications in relation to the use of medical devices during the COVID-19 pandemic. Please see below a summary table of all recent publications:
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Official Journal of the European Union publications |
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Date |
Reference |
Title |
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16/03/2020 |
Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat |
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15/04/2020 |
Communication from the Commission Guidelines on COVID-19 in vitro diagnostic tests and their performance |
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24/04/2020 |
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 concerning medical devices with regard to the dates of application of some of its provisions |
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19/05/2020 |
Communication from the Commission Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 |
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19/05/2020 |
Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies |
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European Commission information and documents relevants |
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Date |
Title |
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20/03/2020 |
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20/03/2020 |
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26/03/2020 |
New 2020 lists of harmonised standards for medical devices are now available |
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15/04/2020 |
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27/04/2020 |
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories |
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03-03-2020 |
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03-04-2020 |
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25-05-2020 |
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context |
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01-07-2020 |
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08-06-2020 |
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23-07-2020 |
COVID-19 In Vitro Diagnostic Devices and Test Methods Database |
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13-07-2020 |
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02-07-2020 |
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08-06-2020 |
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23-07-2020 |
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For more information on medical device, please click here.
Please see the below table summarising the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.
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CENELEC / CEN |
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Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
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Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices |
2023-02-19 |
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Chemical disinfectants and antiseptics - Methods of airborne room disinfection by automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities |
2020-10-31 |
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Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018) |
2023-05-31 |
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Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
2020-11-30 |
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Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) |
2020-11-30 |
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Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) |
2020-11-30 |
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Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020) |
2020-11-30 |
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Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020) |
2020-11-30 |
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Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020) |
2020-11-30 |
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Health informatics - Device interoperability - Part 10201: Point-of-care medical device communication - Domain information model (ISO/IEEE 11073-10201:2020) |
2020-12-31 |
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Please find below a table summarising recent regulatory proposals made to the European Commission (Non-exhaustive):
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Countries |
Notification number |
Title |
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Hungary |
Government Decree No 213/2020 of 16 May 2020 on the operation of cooling/heating systems in the state of emergency |
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France |
Draft Order of 20 May 2020 supplementing the Order of 23 March 2020 prescribing the organisational and operational health system measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency |
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France |
Order supplementing the Order of 23 March 2020 prescribing the organisational and operational health system measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency |
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France |
Decree prescribing the general measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency |
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Sweden |
Regulations amending the Public Health Agency of Sweden’s Regulations (FoHMFS 2014:10) on alcoholic preparations |
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France |
Order applying the reduced rate of value added tax to protective equipment intended for combating the spread of the COVID-19 virus |
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Denmark |
Order on special measures concerning the supply of disinfectants for the management of coronavirus disease 2019 (COVID-19). |
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Denmark |
Order on special measures concerning the supply of medical devices and protective equipment for the management of coronavirus disease 2019 (COVID-19) |
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Denmark |
Order amending the Order on medicinal product emergency response for the management of coronavirus disease 2019 (COVID-19) |
Updates to face mask and respirator policy
In May 2020, the U.S. Federal Drug Administration (FDA) published the following revision to regulation on face masks used by the general public and respirators used by health care personnel (HCP):
This document clarifies the use of face mask and N95 respirators which should only be used if they are FDA-cleared, FDA-authorised, or NIOSH-approved devices. The FDA has noted the importance of performing personalised fit testing.
Below you will find several letters and documents issued by FDA in relation to Emergency Use Authorization (EUA):
- NIOSH approved FFR (28th March 2020)
- Imported Non-NIOSH Approved FFRS from countries other than china (6th June 2020)
- Non-NIOSH Approved FFRs manufactured in China (6th June 2020)
- EUA Source Control for General public and HCP face masks (24th April 2020)
- Umbrella emergency use authorization (EUA)(5th August 2020)
Guidance Documents and other regulatory guidance can be found on the FDA website.
Regulatory proposals notified to WTO
Please see the below table summarising the most recent notifications made to the World Trade Organization (non-exhaustive):
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Notification number / Link |
Country |
Title |
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Peru |
Technical specifications for the manufacture of cloth face-masks for use by the community |
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Switzerland |
Revision of the Ordinance No. 2 on Measures to Combat the Coronavirus (COVID-19) |
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US |
Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests |
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US |
Approval Tests and Standards for Air-Purifying Particulate Respirators |
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Moroco |
Order of the Minister of Industry, Trade and the Green and Digital Economy No. 1060-20 of 14 Chaabane 1441 (8 April 2020) on protective masks of non-woven fabric for non-medical use |
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Peru |
Draft Regulation governing changes to medical devices in the sanitary register |
Transition period information
Please see the below table summarising the most recent publication made to UK authorities (non-exhaustive):
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Date |
Title |
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01-09-2020 |
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01-09-2020 |
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03-08-2020 |
Letter to medicines and medical products suppliers: 3 August 2020 |
