November 3rd the EU Medical Device Coordination Group (MDCG) issued a new guidance concerning the clinical evidence for orphan in vitro diagnostic medical devices.
Like for any medical device under MDR and IVDR, necessary clinical evidence should be based on a sufficient amount and quality of data in order to allow proper assessment of the device’s safety, performance, and the intended clinical benefit(s).
Given the unique challenges for orphan IVDs, however, there are circumstances where it is considered acceptable to place them on the market with limitations in clinical performance data. MDCG 2026-6 provides guidance in this respect.