The European Commission has requested the Scientific committee* to provide guidelines on the benefit risk-assessment of…
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…
Public Consultations: NB and IVD
1. The European Commission will shortly open public consultations in the context of the new…
List of MDR requirements for manufacturers!
The European Commission has published the list of requirements under the MDR that was prepared by…
Irish Authority: Practical Application of the new Regulations
The Irish Health Products Regulatory Authority (HPRA) published Information Pack on the new EU Device…