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....
Dec 2 - 5:58
The Center for Devices and Radiological Health (CDRH), a division of the U.S. Food and Drug Administration (FDA) responsible for pre-marketing assessment and evaluation of medical devices and general supervision on...
Nov 27 - 4:35
The Ministry of Food and Drug Safety (MFDS), Korea’s national authority responsible for medical device regulation (previously known as Korea Food and Drug Administration or KFDA) issued an update to the requirements...
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...
