Aug 30, 2019

Update September 4, 2019: The UK Parliament has struck back at Boris Johnson's attempt to short-circuit debate over a no-deal Brexit, with a vote planned to prevent a hard withdrawal from the EU. Parliament's move will likely result in new UK elections.

Following UK Prime Minister Boris Johnson’s recent end-run around the British Parliament to truncate debate on avoiding a no-deal Brexit, the likelihood that the UK will withdraw from the European Union without significant economic safeguards in place on October 31, 2019 appears greater than ever.

Johnson’s move to suspend Parliament until two weeks the October 31 Brexit deadline extension, now approved by Queen Elizabeth II, reduces the window of opportunity whereby proponents of a more orderly withdrawal from the EU can develop and propose viable alternatives to a no-deal outcome. These latest UK developments should also signal to industries including medical device and IVD manufacturers that preparations for a no-deal withdrawal should continue.

CE Marking, commercialization and related issues in the event of a no-deal Brexit

Emergo by UL consultants as well as some European Competent Authorities have weighed in previously on how medical device and IVD companies should prepare for the effects of a no-deal Brexit.

Some key issues manufacturers should tackle include:

  • Supply disruptions: How would a new hard border between the EU and UK affect access to supplies necessary for manufacturing medical products, as well as distribution of these products to healthcare providers and patients across a hard border?
  • Notified Body partnerships: Medical device and IVD manufacturers currently using UK-based Notified Bodies (NBs) for CE Marking may need to find EU-based NBs in order to maintain certification under current Directives as well as new Regulations. (So far three European NBs and one UK NB have been designated to issue CE Mark certifications under the new Medical Devices Regulation, or MDR.)
  • UK Responsible Person requirements: In the event of a no-deal Brexit, manufacturers currently active in the UK using a European Authorized Representative (or EC Rep) will need to appoint a new in-country representative, a UK Responsible Person, in order to legally market their products in Great Britain.
  • Brexit and MDR: Although we anticipate that the European MDR and IVDR would still apply in the UK following a no-deal Brexit, manufacturers should be aware that information regarding how the Regulations as well as European Commission laws, CE Marking requirements and related issues will function in a UK withdrawn from the EU.

With the chances that a no-deal Brexit will be averted now slimmer than ever, medical device and IVD companies active in the UK and Europe must seriously explore the ramifications of hard borders and distinct market regulatory regimes.

Emergo by UL will provide additional Brexit-related updates as they become available.

Additional European and UK medical device regulatory resources: