The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the matter. However,...
Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers
Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers We have some fantastic news for all medical device manufac...
Timelines for CE Marked Medical Device Placement in the Great Britain Market: UK MDR 2023 Update
UK MDR Update published! It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 – statutory instrument 2023 No...
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...
Have your say!
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...
Proposal for amending the medical devices transition extension was published!
The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transi...