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Medical Devices / Regulatory Affairs

MHRA Updates Device Guidance for No-Deal Brexit

Sept. 6, 2019
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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on how it will handle medical devices if the Britain leaves the EU with no deal on Oct.  31.

“If there is a no-deal Brexit, the UK’s current participation in the European regulatory network for medical devices would end, and the MHRA would take on the responsibilities for the UK market that are currently undertaken through the EU system,” the agency said.

Class IIb implantable devices, Class III devices, active implantable devices and certain in vitro diagnostics must be registered with the agency within four months of the UK’s exit. For all other devices, the agency said it will issue information on when to register them.

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