EU MDCG Latest Update - June 2026

This document clarifies the management of Summary of Safety and Clinical Performance (SSCP) reports for MDR devices and Summary of Safety and Performance (SSP) reports for IVDs following the mandatory use of the first EUDAMED modules. The new feature will first be available in EUDAMED Playground in July 2026 and then in Production in October 2026; For devices placed on the market prior to mandatory use, manufacturers must upload the SS(C)Ps as soon as possible and no later than February 27, 2027.

Practical Impact: This affects MDR manufacturers of implantable and Class III devices, as well as IVDR manufacturers subject to SSP. EUDAMED procedures, internal responsibilities, registration plans, certification checklists, and workflows with Notified Bodies (NBs) must be updated for the validation, upload, and management of SSCP/SSP translations.

MDCG 2021-5 Rev.1 Appendix – Transition to the “EU REP” symbol in EN ISO 15223-1

The appendix clarifies the transition from the EC REP symbol to the EU REP symbol in relation to the amendment EN ISO 15223-1:2021/A1:2025. The change is classified as purely editorial, with no impact on safety, performance, or the authorized representative’s role or responsibilities. The document specifies that prior approval from the Notified Body is not required for the labeling change, if applicable. The Commission published the harmonized references on June 17, 2026, for the MDR and IVDR and has provided for a 5-year coexistence period, until June 17, 2031.

Practical Impact: This primarilyaffects non-EU manufacturers with a European authorized representative. It is recommended to update artwork, IFUs, packaging, master labels, labeling procedures, change assessments, and the matrix of applicable standards. Immediate relabeling is not required, but the transition must be planned by June 17, 2031.