Brexit and the separation of the United Kingdom from the EU have significantly affected a multitude of sectors and their regulatory frameworks. The medical devices sector does not represent an exception. The capacity to assess the safety of medical devices and IVD medical devices is being challenged and, just as in the EU, the demand might be higher than the supply.
Increasing assessment capacities for medical devices and IVDs
In the European Union, Notified Bodies assess the conformity of medical devices and IVD medical devices which do not belong to the least risky categories. In the United Kingdom, Approved Bodies are the equivalent of Notified Bodies.
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has been making steady strides to ensure that patients have access to high-quality medical products, among others, by enhancing the number of Approved Bodies.
UKCA marking from June 2024
From June 2024, the UKCA mark will be the equivalent conformity proof in the United Kingdom. Until that date, manufacturers can place CE marked devices on the markets in England, Wales, and Scotland (Northern Ireland is exempted). To affix the UKCA mark, the intervention of an Approved Body is necessary for certain devices such as Class III, IIb, IIa medical devices as well as IVDs for self-testing.
Last Approved Body for IVDs
In December 2022, the MHRA designated the latest Approved Body. UL International UK LTD can now assess most in-vitro diagnostic devices. This approval further bolsters the capacity to assess the conformity of medical devices. Until now, there were only two Approved Bodies for IVD medical devices: BIS Assurance UK Ltd and SGS United Kingdom Ltd.
In total, the MHRA has designated four Approved Bodies as of February 2023, three of which assess IVDs.
Manufacturers must appoint a Responsible Person in the UK
Obelis UK Ltd acts as your Responsible Person in the United Kingdom, reviewing your documentation and acting as your representative in the country. Despite the latest extension to affix the UKCA mark until June 2024, the requirements to register medical devices with the MHRA and have a UK Responsible Person for non-UK manufacturers are applicable from January 2021.
If you want to place your medical devices and IVD medical devices on the UK market after June 2024, you need an Approved Body to assess your devices. Obelis can help you to select the right Approved Body.
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Nikolaos Chatzistavrou
Regulatory Affairs Department
24/02/2023
Would you like to place medical devices on the UK market? Contact us and we will guide you through the process!
References:
- Gov. UK. (2022). MHRA increases UK assessment capacity for in-vitro diagnostic devices – GOV.UK (www.gov.uk). Retrieved on 23/01/2023.
- Gov. UK. (2022). MHRA appoints first new UK Approved Body to certify medical devices since Brexit. Retrieved on 23/01/2023.
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