Art. 84 Ausnahmen für In-vitro-Diagnostika

Von der Swissmedic erteilte Ausnahmen nach den Artikeln 9 Absatz 4 und 17 Absatz 3 MepV⁶⁴ in der Fassung vom 1. August 2020⁶⁵ bleiben weiterhin gültig.

⁶⁴ SR 812.213

⁶⁵ AS 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.

Dies ist keine amtliche Veröffentlichung. Massgebend ist allein die Veröffentlichung durch die Bundeskanzlei.
This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.