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UK Responsible Person

UK- Medical Device Requirements

From 1st Jan 2021 there are several changes to how medical devices are placed in the UK market, one of the requirements include if you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you will need to appoint a single UK Responsible Person.

A written mandate is necessary between manufacturer and UK responsible person. This mandate needs to be submitted to MHRA for registration purpose.

Responsibility of UK Responsible Person

Registrations in Great Britain

7 Device Registration Process

The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 May 2021:

The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 September 2021:

The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 January 2022:

The following registration data is required for MHRA registration: