What are the implications of Brexit for Medical Device Companies up to December 31, 2020?

The Irish Health Products Regulatory Authority (HPRA) has recently issued a brief explanation of the impact that Brexit will have upon medical devices during the transitional period, namely until December 31, 2020.

The UK officially left the EU on January 31, 2020, after having reached an agreement with the EU on October 17, 2019. However, a transition period was agreed upon and will last, at least, until the very end of 2020. During this time frame, the EU and the UK will negotiate on a future trade relationship which might ultimately resemble the CETA agreement.

Independently from the negotiations outcome, Brexit will result in some changes for Ireland, as a remaining member state of the EU, and companies need to prepare for it.

What are the implications during the transitional period?

In a nutshell:

  • Medical devices with a UK notified body (UK CE mark), UK legal representative or manufacturer can continue to be distributed across the EU and UK;
  • Parallel trade from the UK is permissible;
  • Transferal of CE Certificate to EU 27 NB;
  • Appointing EAR in EU 27;
  • What are the steps to take according to the Irish authority?

As doubts will inevitable emerge during the ongoing Brexit trade-negotiations, the HPRA shall continue to provide clarity, specifically in respect of industry implications of the Withdrawal Agreement and the Northern Ireland protocol, and we will keep you informed.

Carlos Francisco Marín Barrios

Regulatory Affairs Department

04/03/2020

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