Medical Devices | Monthly bulletin | April 2020
Regulatory news - Eurofins updates
Regulatory news
Lack of personal protective equipment a great difficulty in fight against Coronavirus
The outbreak of the coronavirus globally has resulted in the necessity for national authorities to adapt legislation in order to facilitate an increase in the production and distribution capacity of personal protective equipment and an acceleration of product approval, as a result of the lack of PPE available globally.
In Europe, the production of masks and other personal protective equipment (PPE), leave-on hand cleaners and hand disinfectants and 3D printing to facilitate the development of these products, in have become a priority to support the fight against coronavirus.
For this reason, the European Commission has made available the following documents with the aim of supporting manufacturers and market surveillance authorities to ensure these products comply with necessary safety standards and are effective.
On 30th March 2020, the European Commission published the following guidance:
- Conformity assessment procedures for protective equipment (Guidance for manufactures)
- This guidance details applicable EU legal frameworks and steps that manufacturers need to take to place their products on the EU market
- Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
- Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
The following information related to medical devices and personal protective equipment are also of note:
- Recommendation C/2020/1712 (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
With the aim to facilitate the rapid uptake of new products on the EU market
- European standards for medical supplies made freely available to facilitate increase of production (20/03/2020). The standards are available for free download from the websites of CEN national members
For further information about medical devices, please consult the European Commission’s website here. For further information about personal protective equipment, please consult the European Commission’s website here.
In the US, The U.S. Food and Drug Administration (FDA) published the following statement on 24th March 2020:
With the aim of providing instructions to facilitate the import process of products related to the Coronavirus Disease-2019 (COVID-19) public health emergency.
The FDA‘s website has a dedicated section with updated information about personal protective equipment for infection control and outlines specific information about:
- N95 Respirators and Surgical Masks (Face Masks)
- Medical Gloves
- Medical Gowns
- Questions About Personal Protective Equipment (PPE)
- FAQs on Shortages of Surgical Masks and Gowns
The agency is providing maximum flexibility to those seeking to bring PPE into the U.S and is ready and available to engage with importers to minimise disruptions during the importation process.
Proposal to postpone the application date of medical device regulation
On 25th March 2020, the European Commission published SANTE.DDG1.B.6/. In this announcement the Commission indicated that it is working to submit, in early April, a proposal to postpone, by one year, the application date of the medical device regulation as a result of the coronavirus. The application date was scheduled to come into effect at the end of May 2020.
Recent publications by the European Commission
The below table summarises recent publications made by the Official Journal of the European Union relating to medical devices:
|
Date |
Reference |
Title |
|
25-03-2020 |
Decisión de Ejecución (UE) 2020/437 de la Comisión, de 24 de marzo de 2020, sobre las normas armonizadas para dispositivos médicos redactadas en apoyo de la Directiva 93/42 / CEE del Consejo |
|
|
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 |
The below table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):
(*) Date of availability: date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat.
|
CENELEC/CEN |
|||
|
Reference |
Title |
Date of Availability (*) |
Supersedes |
|
Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
2022-11-27 |
|
|
Medicines and Medical Devices Bill
On 13th February 2020, the Department of Health and Social Care published the provisions of the Medicines and Medical Devices Bill which was presented to the House of Commons. It will introduce medical device regulation and provide a regulatory innovative technologies developed.
Regulatory proposals notified to WTO
Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):
|
Notification number |
Countries |
Title |
|
US |
Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology |
Covid-19 | Testing, inspection and certification of products and devices
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