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Alison Dennis

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联系方式

Alison Dennis

合伙人

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2020年9月3日

Alison Dennis discusses the new framework for regulating medical devices and IVDs

As the UK leaves the EU, a new framework for regulating medical devices and IVDs will come into place at the start of next year.

So long, CE mark - and welcome, UKCA. As of 1 January 2021, the UK plans to start phasing out the familiar CE insignia seen on millions of products that meet EU health, safety and environmental protection standards. This will be replaced with the UKCA (UK Conformity Assessed) mark that is associated with the new regulations of a post-Brexit framework.

According to the latest proposal issued by Medicines and Healthcare products Regulatory Agency (MHRA) outlining plans for the regulatory transition, companies have a grace period where CE marking will continue to be used and recognised in the UK until 30 June 2023. Manufacturers of medical devices and in vitro diagnostics (IVDs) will have to register their products first with the MHRA and the products will be assessed by UK Conformity Assessment Bodies (CABs) against UK requirements for the purpose of UKCA marking.

Alison discusses what challenges companies might be facing in complying with these new rules with First Word MedTech, originally published on 2 September 2020.

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