UKCA for medical devices

The UKCA marking is a conformity marking for products being placed on the market in Great Britain (GB) and for medical devices this provides a demonstration of compliance with UK MDR 2002.  

TÜV SÜD is an Approved Body designated by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to provide conformity assessment services for general medical devices, active implantable medical devices and in-vitro diagnostic medical devices under UK MDR 2002. Our dedicated team of experts at TÜV SÜD can offer both UKCA and CE marking services, which provides medical device manufacturers the possibility to minimise costs and time to market for new products across Europe.

The legislation that applies in the United Kingdom (UK) is the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).  UK MDR 2002 outlines UKCA marking requirements for Great Britain which are currently based on requirements derived from the EU legislation for: 

• Active implantable medical devices, Directive 90/385/EEC (AIMDD) 
• General medical devices, Directive 93/42/EEC (MDD) 
• In vitro diagnostic medical devices, Directive 98/79/EC (IVDD) 

Medical devices placed on the Northern Ireland market must meet EU Regulatory requirements and carry a CE or UKNI mark. 

Key requirements for manufacturers intending to place medical devices on the market in the UK include:

• Product registration: All medical devices and IVDs to be placed on the market in Great Britain must be registered with the MHRA. Where applicable, details about conformity assessment by a UK Approved Body for UKCA, or an EU Notified Body for CE must be provided during device registration.  
• UK Responsible Person: If you are located outside of the UK, you will be required to appoint a UK Responsible Person (UKRP), located in the UK. The UKRP responsibilities will include registering your devices with the MHRA. 

The Medical Devices (Amendment) (Great Britain) Regulations 2023 introduces transitional arrangements that extend the acceptance of CE marked medical devices onto the Great Britain market. 

These transitional arrangements include the continued acceptance for CE marked medical devices in Great Britain based on timelines published by the MHRA and include that: 

• General medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking, can be placed on the GB market until the sooner of expiry of certificate or 30 June 2028 
• In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030. 
• General medical devices, including custom-made 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 Great Britain market up until 30 June 2030. 

Changes to the UK medical devices regulations are expected in the future, with key parts of the legislation anticipated to apply from mid 2026. 

These changes are expected to include amendments to scope and classification, alongside targeted measures to reinforce safety and transparency including: 

• Updates to classification criteria, certain devices move to higher risk categories 
• Introducing requirements for Unique Device Identifies (UDIs) 
• Introducing a requirement for implant cards 
• Introducing additional requirements around marketing claims 

Please note that this information is based on current information and guidance. As the planned amendments to the UK Medical Devices Regulations are published and implemented, our current understanding may change. TÜV SÜD will continue to keep you informed on any changes and how they may affect you. 

As a UK Approved Body, and together with our TÜV SÜD organisation, our dedicated team of experts can offer both UKCA and CE marking services. 

By obtaining both UKCA and CE certification through TÜV SÜD at the same time, medical device manufacturers can minimise costs and time to market for new products across Europe.  

For over 30 years, TÜV SÜD has provided certification services and regulatory expertise for manufacturers and suppliers of medical devices and in vitro diagnostic devices.