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Document 32026R0977
OP_DATPRO
Regolamento di esecuzione (UE) 2026/977 della Commissione, del 4 maggio 2026, che stabilisce determinate prescrizioni procedurali e relative alla gestione della qualità uniformi per le attività di valutazione della conformità svolte da un organismo notificato designato a norma dei regolamenti (UE) 2017/745 e (UE) 2017/746 del Parlamento europeo e del Consiglio
- Initiative summary:
- With the planned implementing act, the Commission intends to set uniform rules for the application of the requirements to be met by notified bodies designated under the EU regulations for medical devices. Notified bodies are independent third parties responsible for the assessment and certification of medical devices and in vitro diagnostics. They are designated and regularly monitored by national competent authorities.
- EuroVoc thesaurus:
- specifica tecnica; omologazione; norma di qualità; attrezzature medico-chirurgiche; norma di commercializzazione; marcatura CE di conformità
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- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Committee on Medical Devices
- Planned adoption period:
- 01/10/2025 - 31/12/2025
- Check the status of this initiative on the Better Regulation Portal
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- Documents:
- C/2026/2798 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
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- Documents:
- 32026R0977 (Implementing regulation)