17 Oct 2024 | All the News, MDCG
Theme Conformity assessment bodies assessment with a view to designation as a notified body Target Audience Conformity assessment bodies, notified bodies, designating authorities, joint assessment teams Products concerned MD, IVD Documents mentioned IMDR (EU)...
17 Oct 2024 | All the News, MDCG
Theme Qualification of IVD Target Audience Manufacturers, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 – article 2(2) et 2(4) The purpose of this guidance document is to clarify which products fall within the scope of Regulation (EU) 2017/746 on...
25 Jun 2024 | All the News, MDCG, MDCG
Theme Clinical evaluation Target Audience Manufacturers, NB Products concerned Orphan medical devices Documents mentioned MDR (EU) 2017/745 – article 60 Article 35 of the Charter of Fundamental Rights states These are guidelines for manufacturers and notified bodies...
