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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Medical Devices | Monthly bulletin | April 2020

Medical Devices | Monthly bulletin | April 2020

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Regulatory news - Eurofins updates 

 

Regulatory news


 

Europe/US

 

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:

 

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

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:

 

Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers.

 

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:

 

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.

 

Europe

 

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

C/2020/1901

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

C/2020/1712

Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

 

Standards updates

 

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

EN 55011:2016/A11:2020

Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

2022-11-27

 

 

UK

 

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.

 

US

 

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

G/TBT/N/USA/1589

US

Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology

 

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