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UK Updates Guidance To Reflect EU Medtech Extensions - Pledges Focus On Agility, Innovation

MPs Urge Right Kind Of Medtech Regulations

 
• By Ashley Yeo

The EU’s decision to extend the Medical Device Regulation transition periods for legacy medical device directives products will be mirrored in the UK, which also continues to evolve its post-Brexit medtech regulatory system.

Brexit

The EU’s decision via Regulation 2023/609 to give manufacturers more time for the certification of certain medical devices under the Medical Devices Regulation will be reflected in updated guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The new MDR arrangements are a recognition by the EU of the capacity challenges across notified bodies, said the UK...

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