Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to info...
Important News from Swiss Medtech for medical device Manufacturers, Importers and Distributors!
New guidelines have been released detailing the regulatory requirements for placing “legacy devices” on the Swiss market. This is essentia...
Guidance for Clinical Investigation Plan under MDR: Key Highlights!
The latest guidance document from the Medical Device Coordination Group, – Guidance on content of the Clinical Investigation Plan for clinic...
WARNING – for all Manufacturers of MDD CE legacy products!
DEADLINE – May 26, 2024! ACT NOW! Submitt your application to your Notified Body and keep your foot on the gas. Keep all your MDD legacy pr...
Important Announcement: CE-Marking Extensions and Medical Devices in the UK
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...
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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...