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Medical Devices / Regulatory Affairs

MHRA Will Require ‘UK Responsible Person’ for All Devices, IVDs

Oct. 9, 2019

Non-UK device and in vitro diagnostic makers will have to register their products with a “UK responsible person” if the UK leaves the EU without a deal, the Medicines and Healthcare products Regulatory Agency (MHRA) said in a new guidance.

Much like an EU authorized representative under the EU’s Medical Device Regulation, devicemakers outside the UK must designate a “UK responsible person” with a UK-registered address.

The UK responsible person must ensure that the declaration of conformity and technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out by the manufacturer, the agency says.

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