In May 2024, the United Kingdom government announced the objective to accept medical devices compliant with other countries’ regulations. The UK currently recognizes CE-marked devices from the EU until 30 June 2030. However, introducing other compliance routes might benefit the medical devices’ supply and patients’ health. This could apply already in 2025. Certainly, manufacturers can still opt for the UKCA marking to place medical devices on the UK market.
Countries and jurisdictions proposed for the recognition
Medical devices compliant with the regulations of Australia, Canda, the European Union, and the United States might soon be recognised to access the UK market under certain conditions:
- Manufacturers will need to comply with the applicable law in the country where the conformity has been already completed (e.g., compliance with the EU Medical Devices Regulation – the MDR – for the European Union).
- Medical devices have to be subject to the upcoming UK post-market surveillance (PMS) requirements.
- Labels in English.
- Medical devices have to carry a unique device identifier (UDI).
- Manufacturers have to appoint a UK Responsible Person.
The access routes vary and can follow four different paths: recognition or self-registration with the MHRA, reliance, reliance with device-specific requirements, or reliance with bridged assessment and device-specific requirements.
Some devices are excluded from the recognition, such as custom-made devices, software as a medical device not aligned with UK intended purpose, and others.
UK Responsible Person for medical devices
Since Brexit, all non-UK manufacturers have to appoint a UK Responsible Person if they want to sell their medical devices and IVDs in Great Britain.
As your UK Responsible Person, Obelis will:
- Register devices with MHRA
- Ensure technical documentations have been drawn up
- Keep a copy of technical documentations for competent authorities upon request
- Inform the manufacturer of complaints and incidents
- Represent the manufacturer
Do you have any questions on compliance with medical devices in the UK, the EU or Switzerland?
References:
Gov.uk. (2024). Statement of policy intent: international recognition of medical devices. Retrieved on 29.05.2024.
Simona Varrella
Regulatory Intelligence & Innovation
29.05.2024
The information contained on Obelis UK is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.