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:

*From 1 Jan 2021 the name and address of the UK RP, where applicable, will need to be included on the product labelling where the UKCA mark has been fixed.

Registrations in Great Britain:

Device Registration Process

Device Registration Process:

Where any changes to registrations are made, a £100 standard fee will apply per application.

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: