Medical Device Coordination Group (MDCG) updates – Apr – Jun 2026

DateGuidance NoAbout the guidance
June 2026MDCG 2021-5 rev.1 – Appendix

Guidance on standardisation for medical devices
Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1



June 2026MDCG 2026-4MDCG 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 below.

Guidance MDCG 2019-9 – rev.1 is being revised to assign to the manufacturer, the task to upload the SSCPs in EUDAMED, both the ‘master’ version along with the translations in accordance with Article 29(4) MDR. It is the responsibility of the manufacturer to ensure that the uploaded SSCP is the one validated by the notified body during the certification process. The changes outlined in the revised guidance will be reflected in EUDAMED and will require the notified body to indicate which is the validated SSCP(s), or parts thereof, in accordance with Article 32(1) MDR, by ticking the box(es) corresponding to the relevant Basic UDI-DI(s). This functionality will be available when registering and/or linking the relevant certificate. See the guidance for more details.

This procedure will also apply as to SSP (IVDs).
Apr 2026
MDCG 2026-3		2026 EMDN Version History
Apr 2026MDCG 2026-22025-2026 Annual Revision Change Log
Apr 2026MDCG 2026-1EMDN UPDATE SUBMISSIONS FROM 2025 PUBLIC CONSULTATION AND THE MDCG NOMENCLATURE WORKING GROUP
20 Apr 2026MDCG 2021-24 Rev.1Guidance on classification of medical devices

The purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements. The explanations provide some simplified concepts and are not exhaustive. For details see the MDR and related additional guidance.

The revisions to the document are detailed on page 3.