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…
EU Case-Law on medical devices
On the occasion of the ruling of the German Federal Court of Justice [Bundesgerichtshof – “BGH”] in the “PIP” breast implants scandal, that followed the…
Software as MD: Regulatory guidance from UK
The UK MHRA has published the revised Guidance on medical device standalone software, including apps. The flowchart was created to help manufacturers understand better their specific…
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 May 2017. Application dates derived from the publication date: Entry…
Regulations on Medical Devices adopted today (5 April 2017) !
After the Council, it was today up to the European Parliament to adopt the EU Regulation on Medical Devices (MDR) and the Regulation on in…
Could economic operators quickly get clarification on whether a certain article of MDR/IVDR apply
Here some official EU links that give an answer to this question: 1. Introduction 2. European Court of Justice’s ruling in Case C-583/11 (Article 263…