Background
As noted in a previous Regulatory Update, the Medicines and Healthcare products Regulatory Agency (MHRA) has opened a public consultation on proposed changes to the medical device regulatory framework in GB. This includes the introduction of a new framework that would allow certain medical devices authorized by other countries to be placed on the GB market without needing a UKCA (U.K. Conformity Assessed) marking or certification, although manufacturers would still have the option to use the UKCA process.
MHRA Proposes International Reliance Route for Medical Devices
MHRA Proposes International Reliance Route for Medical Devices
The U.K. MHRA proposes introducing international reliance routes for medical devices placed on the Great Britain (GB) market and seeks input from the public.
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