UK updated Guidance: Register Medical Devices to Place on the Market

Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.

The updates were the addition of a new section 'Coronavirus Test Device Approval (CTDA) and Registering with MHRA'.

All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).

In Great Britain devices must conform to the Medical Devices Regulations 2002 as they apply in Great Britain so that they can be placed on the market and registered with the MHRA.

Registration requirements differ for Northern Ireland.

The MHRA will only accept the registration of devices from manufacturers or UK Responsible Persons that are based in the UK, or from Authorised Representatives based in Northern Ireland (for the purposes of the Northern Ireland market).

The guidance explains the topics such as

1. Who must register

2. When you must register

3. Information required when registering your devices with the MHRA

4. IVDs undergoing Performance Evaluation

5. Coronavirus Test Device Approval (CTDA) and Registering with MHRA

6. Apply to register on the Device Online Registration System (DORS)

7. Fees

8. Review registration

9. Making changes to your registration

10. Public register of manufacturers

11. Reference guides

12. Video tutorials

13. Contact

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