Regulation (EU) 2021/2282COM(2018)51

EU cooperation on Health Technology Assessment

Stage: In force, reached 22 Dec 2021
In force: In force since 11 Jan 2022 · CELEX 32021R2282
Procedure: Regulation
Lead DG: DG SANTE
Last activity: 22 Dec 2021

2 entries · record as of 14 Sept 2026

Where it stands

Latest: Published in the Official Journal, 22 Dec 2021.

2 Apr 2018
- Feedback on adopted proposal closed: EU cooperation on Health Technology Assessment, 7 responses · Commission
22 Dec 2021
- Published in the Official Journal

6 acts

Delegated and implementing acts beneath it

By status: 6 published.

Act	Kind	Status	Adoption
Commission Implementing Regulation (EU) 2025/2086	Implementing · Regulation	Published	Q4 2025
Commission Implementing Regulation (EU) 2025/117	Implementing · Regulation	Published	Q4 2024
Commission Implementing Regulation (EU) 2024/3169	Implementing · Regulation	Published	Q2 2024
Commission Implementing Regulation (EU) 2024/2745	Implementing · Regulation	Published	Q2 2024
Commission Implementing Regulation (EU) 2024/2699	Implementing · Regulation	Published	Q2 2024
Commission Implementing Regulation (EU) 2024/1381	Implementing · Regulation	Published	Q4 2023

Titles link to EUR-Lex where the act has been published.

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Each title opens on the Commission's portal.

Consultation	Feedback deadline	Feedback received
EU cooperation on Health Technology Assessment	2 Apr 2018	7

Summary

Generated

The regulation establishes a permanent EU framework for joint clinical assessments of new health technologies, including medicines and medical devices. It affects pharmaceutical companies, medical device manufacturers, and national HTA bodies. The regulation is currently in force.

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Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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