| Date | Guidance No | About the guidance |
|---|---|---|
| October 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