European Commission and DHSC offer further guidance over medical device authorisation in the event of a ‘no-deal’ Brexit

Both the European Commission and Department of Health and Social Care (DHSC) have sought to offer further guidance over the regulation of medical devices if the UK leaves the EU without a deal on 29th March 2019.

The European Commission Q&A document explains what ‘placing on the market’ is meant in terms of which products can be legally used and distributed in the EU after Brexit. This explains that:

  • a product being placed on the market refers to each ‘individual product’ and not ‘types of products’
  • if a product is sold, the location of the new owner will determine whether the product has been ‘placed on the EU market’
  • a UK manufacturer can only supply products to the EU if they existed before ‘Brexit day’

The guidance also states that UK based Notified Bodies will no longer be recognised by the EU in the event of a no-deal Brexit. This would mean that in this event, products requiring CE certificates must have one issued by a EU27 based Notified Body.

The DHSC have also expanded on their guidance to companies. According to their announcement, the DHSC continues to plan and review their contingencies for a no-deal Brexit.

In doing so, DHSC have identified products routinely imported into the UK from other EU countries. DHSC state they have taken measures to increase stock of these products held at national level.

MAP will continue to monitor and report Brexit contingency planning. Further information can be found through MAP Europe.

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Published on 12. February 2019 in News EU