Recognition of CE-marked devices extended indefinitely following the abolishment of UKCA markings.
The Medicines and Healthcare products Regulatory Agency (MHRA) has recently announced several updates aimed at modernizing MedTech regulation in the UK. These initiatives are designed to improve patient access to innovative medical technologies, enhance economic growth in the UK's med tech sector, and streamline regulatory processes.
Key Updates
- International Reliance Routes: The MHRA is introducing international reliance routes to allow faster access to safe and effective medical devices already approved by trusted regulators in countries like Australia, Canada, and the USA. This move aims to leverage international expertise and reduce regulatory duplication.
- UKCA Marking: The MHRA supports the removal of physical UKCA markings once a Unique Device Identification (UDI) system is fully implemented. This change is part of a broader effort to simplify regulatory compliance while maintaining safety standards.
- Recognition of CE Marked Devices: The MHRA plans to consult on the indefinite recognition of CE-marked devices later this year. This initiative could allow devices compliant with EU standards to continue being used in the UK, potentially easing the transition for manufacturers and ensuring continued access to a wide range of medical technologies.
- Focus on First-in-Market Innovation: The MHRA is focusing the domestic UKCA route on first-in-market innovation, including the use of Artificial Intelligence (AI) as a medical device. This focus aims to support pioneering technologies while ensuring rigorous safety and effectiveness evaluations.
- Risk Proportionate Route for In Vitro Diagnostics: A more risk-proportionate route to market is being introduced for Class B in vitro diagnostic devices. This approach is designed to balance regulatory oversight with the need for timely access to diagnostic tools.
Regulatory Benefits
- Innovation Support: By focusing on first-in-market innovation, the UK encourages the development and adoption of cutting-edge technologies, including AI.
- Regulatory Efficiency: The reliance on international approvals and the streamlining of UKCA marking processes aim to reduce regulatory duplication and enhance efficiency.
- Patient Access: Patients will benefit from quicker access to safe and effective medical devices approved by trusted international regulators.
These updates reflect the MHRA's commitment to fostering innovation, improving patient care, and maintaining the UK's position as a leader in the global med tech industry.
The move to drop the UKCA marking is in response to a recent consultation on the future of MedTech regulation, including AI devices. The move will happen once Unique Device Identification (UDI) is in place, requiring medical devices to be individually identifiable. The MHRA's regulatory approach for MedTech will be risk-proportionate.
The announcement to promote MedTech innovation and adoption, boost patient outcomes, and deliver economic growth is one of a series of steps outlined in the recently published Life Sciences Sector Strategy. The response to a fourth proposal, to extend four pieces of assimilated EU law, was published in February 2025 and has subsequently been actioned.
- The MHRA's move to leverage international reliance routes for medical devices aligns with their efforts to follow global regulatory standards in the science of health-and-wellness, allowing for faster access to innovative medical devices compliant with these standards.
- To streamline regulatory compliance and ensure the continued availability of a wide range of medical technologies, the MHRA plans to consult on the indefinite recognition of CE-marked devices, which adhere to strict European standards for medical devices and medical-conditions.
