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  • 1.  Switzerland-AR and Labelling Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jul-2021 09:19
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Due to Switzerland being considered a 3rd country in the EU, new requirements have occurred. First--does labelling have to be updated within the grace periods for AR designation? Secondly--has anyone had any luck with finding an AR in Switzerland?

    Thanks!


  • 2.  RE: Switzerland-AR and Labelling Requirements

    Posted 07-Jul-2021 03:40
    Edited by Beat Steffen 07-Jul-2021 03:41
    Good morning

    Swissmedic published a guidance regarding the roles and responsibilibities of a Swiss Authorized Representative. It's available in English and you can find it here: Swiss authorised representative (CH-REP) (swissmedic.ch)

    Regarding labeling it says the following (section 3.1): The name of the Swiss authorised representative must be stated on the packaging ("product
    labelling") as per MDR Annex I section 23.2 (d). It is not mandatory for the Swiss authorised representative to be stated on the product itself, in the instructions for use as per MDR Annex I section 23.4 (a) or in the documents enclosed with the product (delivery note, commercial invoice).

    Section 4 then states: The transitional periods defined in Art. 104a MedDO apply to the authorised representative.

    There is no clear statement, neither in the guidance nor in the MedDO (Medical Devices Ordinance) but my interpretation is that the labeling needs to be adapted as soon as the CH REP is nominated and latest after the  grace periods defined in Article 104a of the MEdDO.

    Our company confinis is offering CH REP services - for more information, please reach out to info.ch@confinis.com. 

    Cheers, Beat


    ------------------------------
    Beat U. Steffen
    Founder & CEO
    Sursee, 6210
    Switzerland
    ------------------------------

    Original Message


  • 3.  RE: Switzerland-AR and Labelling Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 20-Aug-2021 08:05
    This message was posted by a user wishing to remain anonymous

    Hello All,

    I was wondering if there are any opinions on if the CH-REP symbol needs to be explained in the IFU along all other symbols?

    Even in the new guidance document (Obligations for authorised representatives, importers and distributors (swissmedic.ch)) this is not mentioned.


    Best Regards!
    Original Message


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