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...

On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to extend the validity of certain device certificates (here is  MDSS’ outline on the proposal extension and on Article 97). See how Switzerland and the UK reacted in their official ...

EUDAMED Production v 2.10 has been released with several new features and improvements. Are you ready for the latest and greatest version of EUDAMED Production? Look no further than version 2.10, which comes with a range of exciting new features and improvements. In this post, we’ll provide yo...

Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation The EU’s Medical Device Regulation (MDR) has brought new requirements for the conformity assessment of high-risk medical devices. This regulation includes the implementation of the Clinical Evaluation ...