Great Britain, 25 February 2026 – The landscape of UK medical device regulation has undergone significant transformation following the UK’s departure from the European Union. Navigating the requirements for Great Britain (GB), Northern Ireland (NI), and the European Union (EU) is essential for manufacturers to ensure uninterrupted market access. The Medicines and Healthcare products Regulatory Agency (MHRA) serves as the sovereign regulator, overseeing MHRA device registration, certification, marking, and registration of all medical devices across the UK. As part of this process, manufacturers may need to appoint a UK Responsible Person to ensure compliance with the new regulatory framework and facilitate the approval of medical devices for the UK market.
WHAT IS THE CURRENT REGULATORY FRAMEWORK IN UK MEDICAL DEVICE REGULATION ?
Great Britain (England, Wales, and Scotland) currently operates under the UK medical device regulation, specifically the UK Medical Device Regulations 2002 (UK MDR 2002). Under this framework, the UK has introduced its own product marking system, the UKCA (UK Conformity Assessed) mark, as a replacement for the CE mark. However, the government has implemented strategic measures to allow the continued use of CE-marked devices for a transitional period. This dual-recognition system, known as UKCA vs CE, is designed to provide stability for manufacturers while the UK moves toward a strengthened future regime. Depending on the device type and its compliance with EU legislation, the timelines for placing CE-marked devices on the GB market extend until 2028 or 2030. Manufacturers may need to appoint a UK Responsible Person to ensure smooth MHRA device registration and ensure compliance with UK-specific regulations.
KEY REQUIREMENTS FOR PLACING DEVICES ON THE UK MEDICAL DEVICE REGULATION MARKET
To lawfully supply medical devices in Great Britain, manufacturers must adhere to three core statutory requirements:
- Mandatory Registration: All medical devices, including in vitro diagnostics (IVDs), custom-made devices, and systems or procedure packs, must be registered with the MHRA before being placed on the market.
- The UK Responsible Person (UKRP): Manufacturers based outside the UK must appoint a single UK Responsible Person. This individual or entity acts on the manufacturer’s behalf to carry out specified tasks, such as device registration and acting as a point of contact for the MHRA.
- Product Marking: Manufacturers can use the UKCA marking to attest that products meet UK MDR 2002 requirements. Alternatively, valid CE marking continues to be accepted according to the specified transitional timelines.
TRANSITIONAL TIMELINES: WHEN DOES CE MARKING EXPIRE IN UK MEDICAL DEVICE REGULATION?
The government has introduced a clear roadmap for the acceptance of CE-marked medical devices in Great Britain to facilitate a smooth transition:
- General Medical Devices (EU MDD & EU AIMDD): Devices compliant with these directives can be placed on the GB market until the sooner of the certificate expiry or 30 June 2028.
- In Vitro Diagnostics (EU IVDD): These can remain on the market until the sooner of the certificate expiry or 30 June 2030.
- EU MDR and EU IVDR Compliant Devices: General medical devices compliant with the EU Medical Devices Regulation (EU MDR) and IVDs compliant with the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) can be placed on the GB market until 30 June 2030.
THE ROLE OF THE UK RESPONSIBLE PERSON (UKRP)
The UK Responsible Person is a critical legal anchor for non-UK manufacturers. Their responsibilities, as set out in the UK MDR 2002, include:
- Ensuring the declaration of conformity and technical documentation have been correctly drawn up.
- Keeping copies of technical documentation and relevant certificates available for MHRA inspection.
- Immediately informing the manufacturer about complaints and reports from healthcare professionals or patients regarding suspected incidents.
Crucial Deadline: Accounts of former GB-based authorized representatives that have not updated their role to UK Responsible Person will be closed if not updated by 30 March 2026.
NORTHERN IRELAND: A UNIQUE REGULATORY POSITION
The rules for Northern Ireland differ from Great Britain as the EU MDR and EU IVDR have applied there since May 2021 and May 2022, respectively.
- CE Marking: This remains mandatory for the Northern Ireland market.
- UKNI Indication: This is required if a UK notified body undertakes the mandatory third-party conformity assessment.
- Authorized Representative: GB-based manufacturers must appoint an EU or Northern Ireland-based authorized representative to place devices on the NI market.
POST-MARKET SURVEILLANCE AND VIGILANCE
Once a device is on the market, the manufacturer’s obligations continue through robust vigilance and post-market surveillance, as outlined in UK medical device regulation. New legislation that came into force on 16 June 2025 has strengthened these requirements in Great Britain to facilitate better risk management and swifter action in the event of safety issues. Manufacturers are required to submit vigilance reports to the MHRA following certain incidents and take appropriate safety actions when necessary. To ensure compliance with these regulations, manufacturers may need to appoint a UK Responsible Person who can support MHRA device registration and facilitate the transition from CE marking to the UKCA mark, in line with the UKCA vs CE discussion.
CONCLUSIONS
The UK’s regulatory framework ensures that medical devices meet high standards of safety and performance while providing a pragmatic transition for those currently using the CE mark. Manufacturers must remain vigilant regarding registration deadlines, the status of their UK Responsible Person, and the upcoming expiration of CE recognition to maintain seamless access to the UK market.