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Regulation (EU) 2022/1122021/0323(COD)COM(2021)627

Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

Amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

Stage
In force, reached 28 Jan 2022
In force
In force since 28 Jan 2022 · CELEX 32022R0112
Procedure
Ordinary legislative procedure
Lead DG
DG SANTE
Last activity
14 Feb 2022
16 entries · record as of 14 Sept 2026

Where it stands

Latest: Plenary sitting, 14 Feb 2022.

Show the earlier record: 5 dates, 14 Oct 2021 to 10 Dec 2021
  1. 14 Oct 2021
    • Adoption by Commission
  2. 15 Oct 2021
    • Discussions within the Council or its preparatory bodies
  3. 18 Oct 2021
    • Plenary sitting
    • Referred to committee
  4. 22 Nov 2021
    • Discussions within the Council or its preparatory bodies
  5. 10 Dec 2021
    • Discussions within the Council or its preparatory bodies
  1. 14 Dec 2021
    • Plenary vote
  2. 15 Dec 2021
    • Plenary adopted first-reading position
    • Plenary vote
    • Plenary sitting
  3. 16 Dec 2021
    • Discussions within the Council or its preparatory bodies
  4. 17 Dec 2021
    • Discussions within the Council or its preparatory bodies
  5. 20 Dec 2021
    • Approval of the EP's first reading position by the Council (adoption of the legislative act)
  6. 25 Jan 2022
    • Signed
  7. 28 Jan 2022
    • Published in the Official Journal
  8. 14 Feb 2022
    • Plenary sitting
4 documents

Documents

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Summary

Generated

This regulation extends the transition period for certain in vitro diagnostic medical devices to comply with EU rules under Regulation (EU) 2017/746, and defers stricter requirements for devices manufactured and used within a single health institution. It affects medical device manufacturers, notified bodies, and hospital laboratories. The act was adopted and entered into force in January 2022.

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

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