Registering Medical Devices for the UK Market

1. Overview and Legal Requirements All medical devices, in vitro diagnostic medical devices (IVDs), and custom-made devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed on the Great Britain market. This requirement applies to all classes of devices. The registration process ensures that the MHRA has a record of the devices available on the UK market to support post-market surveillance. Source: Register medical devices to place on the market (GOV.UK)

2. Who Must Register The responsibility for registration depends on where the manufacturer is based:

UK-based Manufacturers: Must register their own devices.

Manufacturers based outside the UK: Must appoint a single UK Responsible Person (UKRP) based in the UK to act on their behalf and carry out the registration.

Authorised Representatives: For Northern Ireland, if the manufacturer is outside the UK and NI, they must appoint a UKRP or an EU Authorised Representative depending on the specific circumstances of the market. Source: Register medical devices to place on the market (GOV.UK)

3. Great Britain and Northern Ireland Differences The regulatory requirements differ based on the region of the United Kingdom:

Great Britain (England, Wales, and Scotland): Devices must comply with the UK Medical Devices Regulations 2002. Devices typically require a UKCA mark, although valid CE marks are currently accepted under transitional arrangements.

Northern Ireland: Under the Northern Ireland Protocol, different rules apply. Devices must comply with EU regulations (EU MDR and EU IVDR). A CE mark is required for the Northern Ireland market. Source: Medical devices regulation and safety (GOV.UK)

4. The Registration Process Registration is completed through the MHRA online registration system (DORS). Applicants must provide:

Details of the manufacturer and, if applicable, the UK Responsible Person.

Details of the devices, including the GMDN code and the Global Model Number (GMN) if applicable.

Evidence of conformity (such as a Declaration of Conformity or a certificate issued by a UK Approved Body or EU Notified Body). Source: Register medical devices to place on the market (GOV.UK)

5. Statutory Fees There is a statutory fee for every registration application. As of the current guidance, the fee is £240 per application. This fee applies to new registrations and any significant changes made to existing registrations. It is important to ensure that all information is accurate before submission, as the fee is non-refundable. Source: Register medical devices to place on the market (GOV.UK)

6. Post-Market Obligations Once a device is registered and placed on the market, the manufacturer (and the UKRP) must continue to monitor its safety. Any adverse incidents must be reported to the MHRA through the Yellow Card scheme. The MHRA has the authority to take enforcement action if a device is found to be non-compliant or poses a risk to public health. Source: Medical devices: guidance for manufacturers on vigilance (GOV.UK)