Pour les dispositifs qui ne sont pas destinés à l’autodiagnostic et qui sont mis sur le marché conformément au nouveau droit, les informations relatives au mandataire au sens de l’art. 44, al. 1 de la présente ordonnance et définies dans l’annexe I, chapitre III, section 20.2, let. d, RDIV-UE66 peuvent jusqu’au 31 mars 2025 être apposées sur un document accompagnant le dispositif.
66 Cf. note de bas de page relative à l’art. 4, al. 1, let. e.
1 Conformity assessment body designations issued under Section 4 of MedDO69 in the version dated 26 November 201770 shall become void for in vitro diagnostic medical devices.
2 The conformity assessment body that issued the certificates under the old legislation remains responsible for the appropriate surveillance of these devices. It is subject to supervision by Swissmedic.
3 Conformity assessment body designations issued under Section 4a of MedDO in the version dated 1 August 202071 retain their validity for in vitro diagnostic medical devices.
4 If an application for designation as a conformity assessment body according to Section 4a of MedDO in the version dated 26 November 201772 was submitted before 26 May 2022, the designation is issued according to the new legislation.
Ceci n’est pas une publication officielle. Seule la publication opérée par la Chancellerie fédérale fait foi. Ordonnance sur les publications officielles, OPubl.
This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.