The Medical Devices Coordination Group (MDCG) endorsed 4 new documents related to UDI. 1. UDI & Software As a standard rule, new UDI-DI should be affixed…
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 a bit more clarity on the timeline for the adoption of…
EU Public Consultations now open: Designation of NB
Today, the European Commission has opened public consultations on the Commission Implementing Regulation on the Codes for the designation of Notified Bodies under MDR and IVDR,…
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 an overview of the main novelties introduced by the regulatory…
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 a smooth transition of economic operators to the new EU regulatory…
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 consulted on the following link. With regard to in vitro…
Public Consultations: NB and IVD
1. The European Commission will shortly open public consultations in the context of the new MDR on the Draft implementing regulation on codes for the…
List of MDR requirements for manufacturers!
The European Commission has published the list of requirements under the MDR that was prepared by the UK MHRA. 14-pager presents exhaustive list of obligations for…
Irish Authority: Practical Application of the new Regulations
The Irish Health Products Regulatory Authority (HPRA) published Information Pack on the new EU Device Legislation (MDR/ IVDR). The guide contains practical graphs and tables…
AG Opinion: software assisting health professionals to prescribe the correct treatment for patients
In the case of Syndicat national de l’industrie des technologies médicales (SNITEM) and Philips France the French national court asked the Court of Justice of…