Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device i...
Guidance on software classification & other documents
The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is gr...
New information on expert panels published
The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies...