Health

MHRA consultation on UK medical device regulation: Analysis

MHRA consultation on UK medical device regulation: Analysis

Ian Bolland is joined by Ashleigh Batchen, Regulatory Affairs Manager at the British In Vitro Diagnostics Association (BIVDA) to discuss the MHRA’s published consultation on how medical devices and IVDs will be regulated in the UK after Brexit.

They also address experiences that can be learned from the implementation of EU MDR and IVDR in the transition to a new regulation and possible challenges for manufacturers, and when it comes to the capacity of Notified Bodies.

You can read about the consultation here.

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