New Publication – Orphan IVDs – TEAM-NB

Dear Members, please see below update from MedTech Europe. This publication from Team NB outlines it’s position on Orphan IVDs under IVDR, which would also apply to Northern Ireland. It describes the suggested approach that the notified bodies would take when reviewing IVD that qualify as ‘orphan’ IVDs. There is a further meeting planned with the EC regarding the issue…