No-Deal Brexit – Implications to Medical Device Regulations (MDR)

by Innovit Corporate Affairs | February 13, 2019 | Blog

A no-deal Brexit (a disaster to some or the chance trade on our own terms to others) means the UK would leave the European Union (EU) immediately on 29 March 2019, and there would be no agreements in place about what their relationship would be like in future.  It certainly is a precarious situation, especially if politicians can’t agree on what should happen next. With every passing week, it’s still unclear how the EU will respond to the crisis. Yet, of all the outcomes of the Brexit negotiations, a no deal scenario is probably the hardest to prepare for.

The EU’s Medical Device Regulation (MDR) regulation deadline is set for May 26, 2020 and there was concern as to any potential impact of a no-deal Brexit.  Fortunately, the European Commission has provided some new guidance and recommendations for medical devices in such a no-deal Brexit scenario.  On February 1, the Commission issued a Q&A document regarding the certification and placing on the market of industrial products in the event of a no-deal Brexit situation on 29 March 2019.

Here’s an additional link with more information.

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