Jurisdiction(s):
United Kingdom

Key definition

Implementing act definition

What does Implementing act mean? An implementing act is an EU instrument used in practice to set the detailed, technical rules needed to apply existing EU legislation uniformly across Member States. It is usually adopted by the European Commission—exceptionally by the Council—under implementing powers conferred by a legally binding Union act. The concept and procedures are set out in Article 291 TFEU and the Comitology Regulation (EU) 182/2011. Implementing acts are non-legislative and differ from delegated acts (Article 290 TFEU): they do not amend or supplement the basic act, but provide measures for its execution. Forms include Commission Implementing Regulations and Implementing Decisions (directly applicable where...

EU/EEA medical devices and IVDs: MDR/IVDR implementing acts, guidance and reform tracker—EUDAMED, AI Act interplay, UDI, Notified Bodies, classification, clinical and post‑market surveillance (to 2026+)

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note

This Practice Note monitors the development of amending legislation, implementing acts, core guidance and initiatives introduced to help stakeholders apply the EU regime for medical devices and in vitro diagnostic medical devices (IVDs) contained in Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR) (together, the MD Regulations) across all EU Member States as well as Norway, Iceland, Liechtenstein and Turkey.

For a high-level overview of the MD Regulations and their obligations, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation.

This tracker draws on material hosted on the European Commission—Public Health website—Medical Devices sector, comprising:

guidance documents endorsed by the Medical Device Coordination Group (MDCG)
MDCG guidance in progress
the rolling plan of implementing measures under the MDR and IVDR (the rolling plan)
the MDR/IVDR roadmap (November 2017), prepared by the competent authorities for medical devices project (CAMD) and the Commission (the CAMD roadmap)
the MDCG joint implementation and preparedness plan for the MDR
the MDCG joint implementation and preparedness plan for the IVDR

The European Commission’s Directorate‑General for Health...

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Web page updated on 29/05/2026

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