Requirements for those manufacturing and supplying devices in Great Britain

Manufacturers wishing to place a device on the Great Britain market need to register with the MHRA. More information on registrations (including fees) can be found in the MHRA’s registrations guidance.

Where a manufacturer is not established in the UK, they must appoint a UK Responsible Person to register and act on their behalf. See guidance on UK Responsible Persons for more information.

Manufacturers must comply with relevant product marking and conformity assessment requirements for medical devices. See below for guidance on the UKCA marking and UK Approved Bodies, and guidance on CE marking and Notified Bodies for more information.


Requirements for those manufacturing and supplying devices in Great Britain:

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