New session : MDR Clinical Training for Manufacturers
The August 27th session being fully booked, TEAM-NB set up a new ½ day training for manufacturers dedicated to clinical aspects. It is planned on November 20th morning. More info available in [...]
Notified Bodies delegation meeting Commission representantives
NBs representatives invited to present their views on future developpement of the Regulations.
Notified Body Perspective on Future Governance in the EU Medical Device Sector
NBCG-Med and Team-NB committees propose a future governance model based on works and exchanges among NBs. NB-Perspective-on-Future-Governance-in-EU-medical-device-sector-20250728
TEAM NB Position Paper on Orphan under the IVDR V1
The position paper includes a proposal for a definition of an orphan IVD and for an approach to conformity assessment for this type of devices. The paper was developed taking into account [...]
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