Art. 84 Dérogations pour les dispositifs médicaux de diagnostic in vitro

Les dérogations accordées par Swissmedic en vertu des art. 9, al. 4, et 17, al. 3, ODim⁶⁴ dans sa version du 1^er août 2020⁶⁵ restent valables.

⁶⁴ RS 812.213

⁶⁵ RO 2001 3487; 2020 2975

Art. 86

If the manufacturer is domiciled in an EU or EEA state or has designated an authorised representative domiciled in an EU or EEA state, that manufacturer must designate an authorised representative in accordance with Article 44 paragraph 1 for all devices placed on the market as from 26 May 2022 within the following time periods:

a.: for class D devices: by 31 December 2022;
b.: for class B and C devices: by 31 March 2023;
c.: for class A devices: by 31 July 2023.

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.