The European Commission published an updated list of CEN/ Cenelec harmonised standards in the framework of the…
Applications to be designated as NB under MDR/IVDR open from 26 November
6 months after entering into force of the new legislation, the European Commission issued a…
Brexit contingency plan: No-deal scenario
The UK Secretary of State for Health and Social Care sent a letter to all…
MDCG Working Groups: Tasks, Membership, Meetings
The Terms of reference of the following MDCG Working Groups were recently published: MDCG Working…
NEW documents on UDI endorsed by the MDCG
The Medical Devices Coordination Group (MDCG) endorsed 4 new documents related to UDI. 1. UDI…
Timeline on future adoption of EC Implementing Acts
The European Commission has today disclosed implementing measures rolling plan under the MDR and IVDR. The document gives…
EU Public Consultations now open: Designation of NB
Today, the European Commission has opened public consultations on the Commission Implementing Regulation on the…
Introductory guide to MDR/IVDR by the UK regulator
The British MHRA has issued an introductory guide to the MDR and IVDR, which is user-friendly and provides…
From MDD to MDR: New Transition Management Tool now on MDlaw.eu!
TMT (Transition Management Tool) is the new tool accessible on MDlaw.eu, which aims at presenting seven techniques for…
The most recent list of NB
The European Commission’s list of bodies notified under the Directive 93/42/EEC concerning medical devices can be…