Introduction Vigilance is the cornerstone of post-market safety oversight for medical devices in the European Union. Under Medical Device Regulation (MDR) No. 2017/745 and In Vitro Diagnostic Device Regulation (IVDR) No. 2017/746, manufacturers are r
Scenario Introduction A regulatory affairs manager at a mid-sized in vitro diagnostics manufacturer is three weeks out from submitting a dossier to a notified body for CE marking under EU Regulation 2017/746 (IVDR). During a final internal review, th
In pharmaceutical and biotech manufacturing, changes to processes, equipment, or materials must be handled carefully. That’s why change control is a critical part of any company’s current Good Manufacturing Practice (cGMP) system. But when change con
If you’re a manufacturer looking to sell your product in the European market, CE marking is a legal must. It’s more than just a label. It shows that your product meets the European Union’s health, safety, and environmental standards.But getting that
