| Date | Guidance No | About the guidance |
|---|---|---|
| 3 Nov 2026 | MDCG 2026-6 | Clinical evidence for orphan in vitro diagnostic medical devices This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The guidance is relevant to IVDs across all risk classes. Particular attention is given to the clinical performance of orphan IVDs, which forms part of the clinical evidence and performance evaluation requirements stated in IVDR Chapter VI. Where relevant, the guidance should be read in conjunction with other MDCG guidance documents, in particular MDCG 2022-2 on general principles of clinical evidence for IVDs. |
| 30 Oct 2026 | MDCG 2026-4 rev.1 | MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use The summary of safety and clinical performance and the summary of safety and performance (SSCP and SSP respectively), are to be uploaded by the notified body during the process of registering certificates information according to Article 32(1) MDR and Article 29(1) IVDR. This policy is however evolving, as described in this position paper. |
Pharmavibes
medicines-medical devices-regulatory affairs