Europe – Brexit happened. EU MDR looms. 3 key questions on medtech’s future in Europe

The U.K. has left the European Union. However, while U.K. politiciansought to frame that outcome as getting Brexit done, in practice the divorce process is ongoing and many questions critical to the future of medtech remain unanswered.

Here, we look at the current understanding on three key questions for medtech, starting with the status of the Medical Device Regulation and its in vitro diagnostic sibling.

With the U.K. out of the EU, do British companies take part in the new EU MDR rules?

Yes, at least for now. The transition period, also known as the implementation period, runs to at least the end of this year and maintains much of the pre-Brexit status quo. The U.K. remains subject to EU law and, as the government stated during the long negotiations, if legislation « comes into force during the implementation period … it will apply to the U.K. » MDR is due to come into force in May, months before the implementation period ends…