The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023! Subject to Parliamentary approval, the UK pl...
Implementation of Future Regulations for Medical Devices in the UK
The UK government is planning a substantial reform of the current regulatory framework for medical devices in the country. In response to the 2021 con...
UK Guidance update with MORE Submissions & Production API
The UK government has recently updated its guidance for CE marked medical devices in Great Britain with new information on MORE Submissions and Produc...
Crafting an Intended Purpose for Software as a Medical Device (SaMD)
Software as a Medical Device (SaMD) As a Software Medical Device (SaMD) manufacturer, you know that regulatory compliance is key to market success. De...
The UK and Switzerland have embraced the EU MDR extension!
The EU currently leads the way in regulatory standards, with the UK and Switzerland following suit. This is being done for valid reasons, as medical d...
Swissmedic inspects Class I manufacturers in Switzerland!
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...
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...