The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-bin...
Agenda of the MDCG and the MDCG subgroups has been released!
The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below). Most...
IMPORTANT, Important … Guidance for class I manufacturer!
MDCG 2019-15 – Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December. And other guidance...
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...