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COVID 19 Product Compliance and Conformity Assessment

31 March 2020

THE BSIF is continuing to keep members up-to-date with the latest developments. On the 16th of March 2020 the EU Commission published the Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID 19 threat.

Dated the 25th, but published on the 26th of March the UK Government, Department of Business Energy and Industrial Strategy and the Office for Product Safety and Standards has accepted this recommendation for the UK. 

Recommendation (EU) 2020/403 provides in essence a limited derogation from 2016/425 for certain COVID 19 PPE. It only applies for PPE which is for the use of healthcare workers in the fight against COVID 19 and limited to the duration of this crisis. The terms and conditions of the Recommendation must be adhered to. The Recommendation in its entirety is available through this link https://www.bsif.co.uk/wp-content/uploads/2020/03/EU-2020-403-Recommendation-on-Conformity-assessment-and-MS-in-the-context-of-Covid-19-threat-March-2020.pdf 

Notified Bodies must be involved in the procedure and they, and the Market Surveillance Authorities (HSE, HSENI and TS) have been directly advised today by BEIS on its acceptance, its application and their need to support the making available of appropriate PPE which, though it may not have completed the entire Conformity Assessment Procedures under EU 2016/425 or indeed the appropriate Medical Device legislation, can be demonstrated to comply with all the existing Essential Health and Safety Requirements appropriate for that product.

We are all seeing media coverage on PPE which appears unsuitable to protect people adequately. All BSIF members know and appreciate that PPE, which performs properly is essential to protecting the healthcare and general workforces in this country. The recommendation does not move away from that principle, but seeks to enable a timely process so that adequate PPE can be placed on the market.

As we often see in a crisis, PPE and especially FFP masks being offered in the supply chain which does not comply.  Frankly, at the moment there are an overwhelming amount of these offers in the UK market. Everyday we have new examples of extremely questionable products supported by counterfeit certification. The most common product is perhaps the KN95 mask (a Chinese domestic standard) supported by unacceptable certification claiming compliance with EN 149!! The Recommendation published and the circumstances of COVID 19 do not allow the placing on the market of these products.

Products which perform, are essential in keeping workers safe. If you wish to place a product on the market that is not already fully compliant with EU 2016/425 or the Medical Device legislation you must follow the terms and conditions of EU 2020 403.

Just for information, I heard today of an importer in Europe who took the opportunity to buy masks that they were led to believe, were compliant and fit for purpose, and they paid upfront. They were not compliant acceptable products. They were misled and it cost them hundreds of thousands of pounds. Do not fall victim to this and more importantly do not allow PPE users to be victims through using non compliant unsafe PPE.

Finally I would like to reiterate that PPE being placed on the UK market which is not already fully compliant with EU 2016/425 or the Medical Device Legislation must comply with the terms and conditions of recommendation 2020/403 and only where it is to be used by workers in Healthcare. Paragraph 8 of the adoption of the Recommendation is very clear stating “ …that such products are only available for the healthcare workers for the duration of the current crisis and that they are not entering the regular distribution channels and being made available to other users”.

In closing I would like to thank the membership for all their efforts at this time and ask you to join me, in applauding the healthcare workers of the country, for whom above and beyond is constant and going the extra mile is part of their journey everyday.