U.K. Regulatory Compliance Guidelines To Change Post-Brexit

The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined its plans for revised post-Brexit guidelines. These regulations will affect medical devices put on the market in England, Scotland, and Wales, while Northern Ireland will have a separate set of rules.

While the U.K. left the European Union (EU) in January of this year, it is still in the midst of its lengthy transition period. Earlier this year, a one-year extension was implemented for the regulations, due to disruptions caused by the COVID-19 pandemic. The transition period is set to end on December 31, 2020.

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The U.K. has been under EU rules for medical device regulation, but beginning January 1, 2021, it will have to roll out its own guidance. Starting on that date, there will be a 4-month grace period for registering for Class IIIs and Class IIb implantables, as well as all other active implantable medical devices; an 8-month grace period for other Class IIb and all Class IIa devices; and a 12-month grace period for Class I devices, except for those manufacturers of Class I devices and in vitro devices that are already required to register with the MHRA.

Manufacturers with businesses based outside of the EU will be required to appoint an authorized representative based in the EU, if conducting business there. Unlike previous guidelines, the new guidelines will require manufacturers based outside of the U.K. to appoint a “U.K. Responsible Person” if they wish to place medical devices on the U.K. market. This person must be established in the U.K., and will be responsible for keeping up with all technical and legal documentation, providing the MHRA with any requested documentation, obtaining samples for the MHRA to approve, informing manufacturers of complaints or incidents associated with their products, and terminating relationships with non-compliant manufacturers.

These guidelines and proposals are still awaiting parliamentary approval, and primarily focus on the short-term effects of the U.K.’s departure from the EU. The long-term implications Brexit will have on the medical device market remain largely undecided. Discussions are scheduled to be held in the fall over guideline enforcement, travel in and out of the U.K., data sharing, and how to best handle these concepts in light of not only Brexit, but the global health crisis.