How to do medical device registration with the Medicines and Healthcare products Regulatory Agency (MHRA)?
The following steps are followed to register a medical device in the UK market as per the news released by MHRA on 10 Jan 2024.
What can be registered?
Before being sold in the United Kingdom, all medical equipment, including IVDs, specially designed devices and systems, procedure packs, must be registered with the MHRA.
Which regulations must they conform to?
For a device to be placed on the market and registered with the MHRA, it must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they are implemented in Great Britain.
What are the registration requirements in Northern Ireland?
Only device registrations from manufacturers, UK Responsible Persons with UK addresses, or Authorised Representatives with Northern Ireland addresses will be accepted by the MHRA (for the Northern Ireland market).
Who needs to register?
- Devices that you have produced that are Class I, IIa, IIb, or III
- Any system or procedure pack that includes at least one medical equipment, whether it be a Class I, IIa, IIb, or III device that you have refurbished or re-labelled under your own name
- Custom-made devices
- IVDs that you have manufactured and are undergoing performance assessment.
How to register your device to be placed in Great Britain Market?
A single UK Responsible Person must be designated by the manufacturer if their headquarters are located outside of the UK to assume accountabilities for all their medical devices.
Note: Since January 1, 2022, the MHRA registration system has suspended the accounts of any represented manufacturers and any former Authorised Representatives based in Great Britain who have not updated their role to UK Responsible Person. This suspension will continue until the UK Responsible Person has updated their role.
A statutory fee will apply per application.
Who are not required to register with the MHRA?
Distributors and suppliers are not required to register with MHRA.