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....
UKCA Post-Market Surveillance Requirements for Medical Devices
UKCA post-market surveillance (PMS) is a legal obligation under the UK Medical Devices Regulations, overseen by the MHRA. It requires medical device manufacturers to maintain a structured system for monitoring device safety and performance after market approval. The...
Introduction to UK Conformity Assessed (UKCA): Requirements
UK Conformity Assessed (UKCA) is the United Kingdom’s product marking introduced on 1 January 2021 after Brexit. UKCA shows that a product meets the health, safety, and environmental protection standards required by UK law. It applies to goods sold in Great Britain...
How to Transition from MDD to MDR? 5 Core Steps
European Union Medical Device Regulation (EU MDR) has replaced the previous Medical Device Directive (MDD). It aims to address gaps in oversight and improve patient safety. EU MDR introduces stricter requirements for clinical evaluation, post-market surveillance,...