UK Approved Bodies for Medical Devices and IVDs

UK Approved Bodies for Medical Devices

What are UK Approved Bodies for Medical Devices and IVDs?

A UK Approved Body is a third part conformity assessment body for market access to Great Britain (England, Wales and Scotland but not Northern Ireland). Under the current UK MDR 2002 UK (SI 2002 No 618, as amended) legislation, medical devices and IVDs, except low-risk devices as defined in the UK MDR, must secure UKCA marking from a UK Approved Body before a manufacturer can place a UKCA-marked medical device on the market in Great Britain, alternatively they can use a valid EU CE mark to support market access until the 30thJune 2030. 
The UK MDR 2002 will transition to a new regulation after 30th June 2025, more information is expected from MHRA about the requirements of the new regulation in Q3 and Q4 2024 and Qserve will keep you informed on this website.

MHRA have published guidance on the Implementation of the Future Regulations which includes a useful infographic explaining the transitional arrangements 

The Medicines and Healthcare Products Regulatory Agency

Which UK approved bodies are designated? 

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the national competent authority for both Great Britain and also Northern Ireland (NI). NI will continue to follow the EU requirements as part of the post BREXIT agreements, so MHRA is a Competent Authority under both UK MDR and also the EU MDR and IVDR. The UK MDR 2002 describes the use of “approved bodies”, the UK does not use the term notified bodies; however an approved body is a third-party conformity assessment bodies in Great Britain in a similar way to a notified body in the EU. 
MHRA designates UK Approved Bodies to certify medical devices and IVDs. Before appointing a UK Approved Body, the MHRA conducts a detailed assessment to ensure that the organization meets the relevant requirements to conduct conformity assessment to UK MDR expectations. Once all conditions are satisfied, the MHRA will designate that organization as a UK Approved Body for a maximum period of five years, during which time they are regularly monitored to ensure they continue to meet the requirements. The designation of UK Approved Bodies is separate from the designation of EU Notified Bodies, so it is essential to check whether your notified body is also an approved body.

The UK government publishes guidance documents on UK Approved Bodies listed under UK MDR. The MHRA published a list of approved bodies and the scopes they are designated under are found here: medical devices uk approved bodies. 

 
The UK approved bodies have a trade association called Team-AB similar to Team-NB and they can be followed on Linkedin.

What should I do now to transition to the UK MDR?

The new UK regulation is still evolving so it is essential to monitor the publication of the new requirements as they emerge. There will be three pieces; Post Market Surveillance legislation in 2024, Core regulation 2024-25 and the Enhance regulation in 2026.

Qserve is closely monitoring the requirements and will publish blogs and webinars here. Once the new regulations are published Qserve will be able to support your transition including;

• Create a strategy for UK market access or transition to the new UK-MDR
• Determine the advantages and disadvantages of conformity routes for the UK including  reliance and recognition of CE marking of FDA versus UKCA marking.
• Selection of a UK approved body if required
• Training on UK MDR and UKCA marking
• Technical file preparation for UKCA marking
• UK Approved Body services

How do you get a medical device or IVD approved in the UK?

The MHRA publishes guidance on the conformity assessment processes for 

• Medical devices
• IVDs