Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers We have some fantastic news for all medical device manufacturers out there! The European Commission has just released the results of a recent survey that sheds light on the progress of the Medical Device Regu...

BSI supports its clients with their own FAQ We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the latest extension (Regulation (EU)2023/607) has been published. We would also like to thank our clients for their valuable feedback, which greatly contri...

EU proposes Master UDI for contact lenses The European Union has introduced a new initiative for a Master Unique Device  Identification (UDI) Device Identifier (DI) (Master UDI-DI) for highly individualized contact lenses. The UDI system is designed to improve traceability and accountability for me...