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...
New Guidance published by the Commission!
The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR)(hereafter called the Medical DevicesRegulations) have ...
European Commission offers Guidance on UDIs!
Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device i...