Despite warnings about hold-ups at Notified Bodies and products failing to be certified under the new Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU)… Read More
Month: May 2019
The World Health Organisation’s (WHO) New Draft Guideline
The WHO is looking for comment on its proposal to combine the features of good storage and distribution for medical products into a single guidance document and will be applicable… Read More
EU Authorities Might Review Products in Case of Notified Body (NB) Shortage
It seems that the medtech system is on course for calamity because NB designation under the new EU Regulations 2017/745 and 2017/ 746 on medical devices and in vitro diagnostic… Read More