Dec 11 - 4:39
The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit. A General Overview of...
Dec 3 - 4:28
The new regulation adopted in Slovenia implements the labelling requirements set forth in the Commission Delegated Regulations 2016/161/EC supplementing Directive 2001/83/EC. The regulation provides detailed rules on...
Dec 3 - 3:33
The European Council, the European body defining the general directions of the EU policy, recently announced they have published the draft of the second corrigendum to the Medical Devices Regulation (MDR) 2017/745....
Nov 27 - 2:26
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued a final version of the assessment form intended to be used by designated authorities to select a notified body. Notified Bodies and...
Nov 18 - 6:08
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued guidance on certain transitional provisions regarding European Union medical devices regulations. MDCG on Transitional Provisions ...
Nov 13 - 2:35
The European Commission has announced the extension of the application period for medical device and in vitro diagnostic device expert panels. It is intended that experts will be able to provide technical and...
