UK MHRA Issues More Guidance Ahead Of New Device Regulatory System For 2021

The MHRA has published more guidance on UKRPs and UK product registrations to help medtech companies navigate the new system and continue to reach the market.

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Device and diagnostic manufacturers located outside the UK must appoint a UK Responsible Person (UKRP) as soon as possible from 1 January 2021. That requirement is contained in new guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA), issued on 8 December.

The guidance also states that the agency will only accept the registration of devices from manufacturers or UKRPs that have a place of business in the UK, or from...

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