The Great Britain medical device and IVD market is regulated by the MHRA under the UK Medical Devices Regulations 2002 (UK MDR 2002). Since Brexit, Great Britain has developed its own regulatory pathway, while continuing to recognise certain CE-marked devices under transitional arrangements. All medical devices and IVDs must be registered with the MHRA before being placed on the GB market.
Core compliance requirements include:
- MHRA device registration
- A UK Responsible Person for non-UK manufacturers
- Appropriate technical documentation
- Conformity assessment and CE or UKCA marking, as applicable
- Ongoing post-market surveillance and vigilance
Since 16 June 2025, strengthened post-market surveillance requirements apply to medical devices and IVDs placed on the GB market, requiring manufacturers to more actively monitor device safety and performance throughout their lifecycle.
The UK regulatory framework continues to evolve, with further reforms to pre-market requirements, international recognition routes and IVD regulation being developed as part of the future medical devices regime.
Frequently Asked Questions
Medical devices placed on the Great Britain market must comply with the UK Medical Devices Regulations 2002 (UK MDR 2002). Key requirements include determining the appropriate regulatory route and conformity assessment, maintaining compliant technical documentation, applying the applicable CE or UKCA marking, and completing MHRA Product Registration before the device is placed on the market. Manufacturers based outside the UK must also appoint a UK Responsible Person to act on their behalf.
Yes. Manufacturers that are not established in the UK must appoint a UK Responsible Person before placing medical devices on the Great Britain market. The UK Responsible Person acts on behalf of the manufacturer in relation to specified regulatory obligations and can register the manufacturer’s devices with the MHRA.
The UKCA mark is the UK’s conformity marking for medical devices and demonstrates compliance with the applicable requirements of the UK MDR 2002. However, Great Britain currently also recognises certain CE-marked medical devices under transitional arrangements, meaning the appropriate market-access route depends on the device and its certification. Manufacturers pursuing the UKCA route may need a UK Approved Body depending on the device classification, making UKCA Marking Guidance and Approved Body Selection important parts of regulatory planning.
Manufacturers must maintain technical documentation demonstrating that their device meets applicable safety, performance and regulatory requirements. The documentation required depends on the type and classification of the device and may include information on its design, intended purpose, risk management, testing, clinical evidence, labelling and conformity assessment. A Technical Documentation Review can help identify compliance gaps before registration or conformity assessment. Manufacturers exporting eligible UK-registered medical devices may also require a Certificate of Free Sale issued by the MHRA to support access to certain international markets.
