Medical devices A new version (June 2026) of the “MDCG Position Paper: Management of the Summary of Safety and Performance in Eudamed after Mandatory Use” has been published. T1, T2, T3 Read more " July 10, 2026
Medical devices Version 7.3.1 of the manufacturer’s adverse event reporting form. T1, T2, T3 Read more " July 10, 2026
Medical devices A new version (v.8) of Chapter 1, “Registration Requirements for the Production Environment,” of the “PMS Implementation of ISO Standards for the IDMP in Europe” has been published, along with Annexes A and B, “Registration Requirements for the Test Environment” (Version 2). T1, T2, T3 Read more " July 10, 2026
Medical devices From 01/05/2026, the use of version 7.3.1 of the Manufacturer Incident Report (MIR) form is mandatory for manufacturers. T1, T2, T3 Read more " May 8, 2026
Medical devices The EUDAMED four first modules (Actor registration, UDI/Devices registration, Notifies Bodies & Certificates and Market Surveillance) will be mandatory to use as from 28 May 2026 T1, T2, T3 Read more " December 10, 2025
Medical devices The new Manufacturer incident report (7.3.1) for medical devices has been published. T1, T2, T3 Read more " June 4, 2025
Medical devices A new version of the document ‘List of Union reference dates and frequency of submission of PSURs’ has been published (Rev. 145) T1,T2,T3 Read more " February 28, 2025
Medical devices MDCG has published an update of the document ‘Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 T1,T2,T3 Read more " February 11, 2025
Medical devices A new version (Nov 2024) of the Q&A document on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR has been published. T1,T2,T3 Read more " January 15, 2025
Medical devices The Medical Device Coordination Group has published the revision 2 of the Q&A document of vigilance terms and concepts as outlined in the R 2017/745 and R 2017/746 T1,T2,T3 Read more " January 15, 2025
Medical devices Revision 2 of the ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD’ has been published. T1, T2, T3 Read more " May 2, 2024
