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.

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.