European Commission Answers Vital Questions In Second Major Brexit Response
European Commission issues Q&A document to help industry understand specifics of “placing” products on the EU market in the context of Brexit, and what needs to be done regarding responsible persons, importers and certificate transfers.
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The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.
The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.
Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.