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Brexit and the MDR—what will happen after transition period?


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There is uncertainty about the extent to which MDR rules will apply in the UK after the end of 2020, which is the current deadline for the end of the Brexit transition period. (Image: Nito/Shutterstock)


Tue. 25. February 2020


BRUSSELS, Belgium: The UK officially left the EU on 31 January 2020 with a withdrawal act providing for a transition period until the end of 2020. A specific question to be considered is whether the UK will take part in the new EU medical device regulation (MDR) after this transition period.

This transition period, also known as the implementation period, is the period during which the pre-Brexit status quo is maintained. An extension of this period is possible through mutual agreement and only if it has been decided on before 1 July. Currently, an extension seems very unlikely. Until the end of the transition period, the UK remains subject to EU law, and EU legislation that enters into force will also enter into force in the UK. This also applies to the MDR, which will enter into force in May, just two months before the deadline for a possible extension of the transition period.

In theory, the UK could unilaterally stop applying MDR rules after the transition period ends. In the case of the EU in vitro diagnostic medical device regulation (IVDR), the UK never needs to adopt the rules at all, as the IVDR is due to take effect only after it leaves the EU. However, the UK government has consistently stated a desire to retain aspects of EU life science law, most explicitly in its no-deal preparations. An example was the UK MDR 2019, into which the UK planned to transpose all the key elements contained in the EU MDR and the EU IVDR in line with the transitional timetable followed by the EU.

The UK eventually decided to abandon its UK MDR 2019 plans after it struck the withdrawal agreement. Still, the document reflects the actions the government was prepared to take in the event that it was completely freed from EU law. One thing to keep in mind, however, is that, although the UK can transpose the MDR into its own laws, the country may be cut off from some of the EU systems that facilitate these regulations.

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