BSI supports its clients with their own FAQ We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the la...
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EU proposes Master UDI for contact lenses The European Union has introduced a new initiative for a Master Unique Device Identification (UDI) Device ...
Extension of the MDR for legacy devices!
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 devi...
New Features and Improvements in EUDAMED
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 P...
Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation
Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation The EU’s Medical Device Regulation (MDR) has brough...
Standard Fees for Notified Bodies under MDR and IVDR
Standard Fees for Notified Bodies under MDR and IVDR The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2 This docume...
The MDCG Position Paper On The Temporary Use Of Article 97 Of The MDR
Article 97 – Expiring medical device certificates (Temporary application of Article 97 MDR) The Medical Devices Coordination Group’s (MDCG...
Products without an intended medical purpose!
Products without an intended medical purpose! The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the grou...
EU MDR Bridge
EU MDR Bridge Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy ...