Due to the lack of an update to the Mutual Recognition Agreement (MRA) zwischen der EU und der Schweiz, hat die Schweiz Maßnahmen festgelegt, zu denen u.a. die gestaffelten Fristen für die Benennung eines Bevollmächtigten „CH-REP“ zählen.
Hersteller höher als Klasse I klassifizierter Medical Devices classified higher than Class I (MDD/MDR) must already have appointed a CH-REP since 31 December 2021 (Impl. IIb, III, AIMD) or 31 March 2022 (IIa, IIb).
The authorisation and registration is carried out using a special mandate form, which the CH-REP sends to Swissmedic, the Swiss Agency for Therapeutic Products, together with its own data and the data of non-Swiss manufacturers.
In the near future, by 31.07.2022, to be precise, all Class I medical device manufacturers and manufacturers of systems and treatment units (MDD/MDR), that export to Switzerland must be able to present a corresponding CH-REP and list its contact details including the CH-REP symbol on the labelling or on the accompanying documents (labelling transition period until 31.07.2023). Here is an overview:
MDD/AIMDD and MDR products:
- Class III, IIb implantable and AIMD: 31 December 2021
- Non-implantable class IIb, class IIa: 31 March 2022
- Class I: 31 July 2022
- Systems and treatment units: 31 July 2022
If you do not yet have a CH-REP, please contact us, as soon as possible so that you can continue to export to Switzerland without transition.
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