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UKCA for medical devices

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UKCA Certified

What is UKCA for medical devices

UKCA (UK Conformity Assessed) marking came into force for products being placed on the market in Great Britain (GB). UKCA marking of medical devices 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 all general medical devices and active implantable medical devices under UK MDR 2002 and is in the application stage of designation for in-vitro diagnostic medical devices. TÜV SÜD dedicated team of experts 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.

 

What is UK MDR 2002?


The legislation that applies in the United Kingdom (UK) is the UK 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. Note that registration requirements differ for Northern Ireland. 
  • 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. 

 

CE Transitional Arrangements 

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 the following timelines: 

  • Devices that can be placed on the Great Britain market until the sooner of expiry of certificate or 30 June 2028 – 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.
  • Devices that can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030 – In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD).
  • Devices that can be placed on the Great Britain market up until 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). 

 

Future of UK MDR 

Changes to the UK medical devices regulations are expected in future, with key parts of the legislation anticipated to apply from July 2025. 

Further additional legislation is expected to be published that will implement strengthened post-market surveillance requirements, for medical devices placed on the market in the United Kingdom. Under these new PMS requirements manufacturers will be required to produce PSUR for each device placed on the market or put into service. 

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. 

How TÜV SÜD can help you with UKCA for medical devices

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. 

Get started with TÜV SÜD 

Start your UKCA for medical devices journey with us.