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Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

The guidance provides clarification on the meaning of the conditions to be applied by the notified body to determine whether it has to consult the expert panel on the performance evaluation report of the manufacturer, and on the corresponding procedures to be followed by the notified body.

Read the guidance published on August 2021 here


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (8 mars 2022). Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o5tj


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