Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative -

Labelling Requirements – Swiss Authorized Representative

Swiss Authorized Representatives shall be referred to as CH-REP in accordance to the Medical Device Ordinance.

Any medical device manufacturer not based in Switzerland shall sell their products in the Swiss market only after a Switzerland based Authorized Representative is appointed.

Labelling Requirements – Swiss Authorized Representative -

The name of the Swiss Authorized Representative must be present on the product label.
However, it is not mandatory to mention the same in the instructions for use, on any
documents related to the product or on the product itself. The name and address details of
the Authorised Representative must appear adjacent to the symbol.
The symbols should
conform to the global harmonized standards failing which the intention and description of
the symbol should be elaborated.

Size of the symbol:

The relative size of the symbol and the size of the name are not defined, but they must be clearly legible to the naked eye.

After May 26 2021, manufacturers based in the EU or EEA states (who may or may not have
an authorized representative in the EU or EEA) are required to appoint a Swiss Authorized
Representative according to the Medical Device Regulation.

For Class III devices, Class IIb implantable devices and active implantable devices, authorized
representatives should be appointed within December 21, 2021, for Class IIb nonimplantable devices and class IIa devices within March 31, 2022 and for class I medical
devices within July 31, 2022.

MDR: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on
medical devices

Art 51 para. 1 MedDO

Product Labelling: MDR Annex 1 Section23.2 (d), section 23.4 (a)

Transition period rules: Art 104aMedDO

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