UKCA Medical Device Classification System: Your Guide
UKCA classification rules for medical devices follow the UK Medical Devices Regulations 2002 (UK MDR 2002). It mirrors EU MDR principles but apply specifically to Great Britain. UKCA medical device classification determines the conformity route. Thus, higher the risk...
UKCA Technical Documentation Requirements & Elements
UKCA technical documentation for medical devices must demonstrate compliance with UK MDR 2002. It should include evidence of safety and performance and be audit‑ready for MHRA or UK Approved Bodies. The documentation is a comprehensive record covering design,...
10-Step Guide for a Smooth CE to UKCA Transition
CE marking will continue to be accepted in Great Britain until 30 June 2028 for medical devices. It will be accepted until 30 June 2030 for IVDs. Then, UKCA marking will become mandatory. Manufacturers should prepare now by appointing a UK Responsible Person....