Swissmedic evaluated compliance declarations from a random sample of 27 Swiss manufacturers of Class I medical devices between August and December 202...
Official Q&A on the extension of the MDR published!
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...
Key Terms in the Medical Device Regulation
Key Terms and Concepts in the Medical Device Regulation – Vigilance The vigilance requirements under the EU’s medical device regulations c...
MDCG Guidance Document on IVD classification
MDCG guidance document on IVD classification If you’re involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the ...
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...
Handling of Certification Gaps according to MDCG 2022-18
Handling of Certification Gaps according to MDCG 2022-18 Introduction The Medical Device Coordination Group (MDCG) has released a new document that pr...
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...