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 1 - 4:02
According to the information available, the implementation of Eudamed database could possibly be delayed for 2 years. Information on the delay was published for the first time after the medical device forum that took...
Oct 17 - 5:30
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745...
Sep 19 - 6:04
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to...
