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Document 32026R1451
Expansion of the list of well-established technologies
Rozporządzenie delegowane Komisji (UE) 2026/1451 z dnia 20 marca 2026 r. zmieniające rozporządzenie Parlamentu Europejskiego i Rady (UE) 2017/745 w odniesieniu do wykazu wyrobów do implantacji i wyrobów klasy III zwolnionych z obowiązku przeprowadzania badań klinicznych
- Initiative summary:
- The proposed delegated act will expand the list of well-established technologies referred to Regulation (EU) 2017/745 on medical devices with a view to exempting them from some legal requirements and reduce administrative burden, without compromising health and safety.
- EuroVoc thesaurus:
- norma bezpieczeństwa; prawo sanitarne; sprzęt medyczny; harmonizacja norm; zezwolenie na sprzedaż; badanie kliniczne; norma jakości; oznakowanie zgodności CE
- See the lifecycle of this act on the Interinstitutional register of delegated acts
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- Leading service:
- Directorate-General for Health and Food Safety
- Expert group:
- Medical Device Coordination Group
- Planned adoption period:
- 01/01/2026 - 31/03/2026
- Check the status of this initiative on the Better Regulation Portal
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- Documents:
- C/2026/1798 final (Delegated regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Foreseen end of objection period:
- 20/06/2026
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- Documents:
- 32026R1451 (Delegated regulation)