2026/2660(DEA)SANT

List of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device

Commission Delegated Regulation amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device

Last activity: 25 Mar 2026

1 entry · record as of 12 Oct 2026

Where it stands

Latest: Referred to committee, 25 Mar 2026.

25 Mar 2026
- Referred to committee

Summary

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A Commission delegated regulation would amend Regulation (EU) 2017/745 (the Medical Devices Regulation) by revising the list of class IIb implantable devices exempted from the obligation to assess technical documentation for every device. It affects medical device manufacturers, notified bodies and importers placing such implants on the EU market.

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Sources: EP Legislative Observatory. Record as of 12 Oct 2026. Something wrong on this page? Report an error.

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