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…
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…
EU Case-Law on medical devices
On the occasion of the ruling of the German Federal Court of Justice [Bundesgerichtshof –…
Software as MD: Regulatory guidance from UK
The UK MHRA has published the revised Guidance on medical device standalone software, including apps.…
Application dates of the Regulation on Medical Devices (MDR)
The Regulation on Medical Devices has been published in the Official Journal of the EU on 5…