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  • 1.  Swiss authorized rep on labeling

    Posted 15-Jan-2024 19:30

    I have a quick question on labeling as it relates to Swiss IvDO requirements.  

    After reading the IvDO and the EU IVDR, it appears that we are only required to identify the Authorized Representative on the product label and not on the accompanying IFU.

    Rationale based on

    Article 15 of Swiss IvDO states: Product information comprises the labelling and instructions for use. It is governed by Chapter III of Annex I to EU-IVDR

    EU IVDR Annex I Chapter 3

    Annex I Chapter 3 does not require the authorized representative to be listed on the instructions for Use or Instrument Operator Manual.

    Q) May you please confirm if this assessment is accurate?



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    Paula Morgan
    Vice President, Quality and Regulatory Affairs
    Accriva Diagnostics, Werfen Whole Blood Hemostasis
    Encinitas CA
    United States
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  • 2.  RE: Swiss authorized rep on labeling

    Posted 16-Jan-2024 04:10

    Hi Paula,

    Yes that is correct, we have been supplying a Swiss company for over 12 months, just make sure the label includes the CH REP symbol, the CHRN-AR number, the Authorised Representative's name, address and email and email are included. Remember if you are using a different company as an import to include their CHRN-IM number, name, address and email as well.

    Kind regards,

    John



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    John Carnegie
    Quality and Regulatory Manager
    Huddersfield
    United Kingdom
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    Original Message


  • 3.  RE: Swiss authorized rep on labeling

    Posted 16-Jan-2024 12:34

    For IVDs in Switzerland, listing the CH-REP information on only the device label is sufficient to meet the requirements.

    Outside of the IvDO, Swissmedic released an information sheet that provides further explanation on where to list the CH-REP on the labeling. The information sheet is available here on their website (downloadable PDF: MU600_00_016e_MB Obligations Economic Operators CH (PDF, 4 MB, 01.11.2023)).

    The required location depends on the type of product and leveraged regulation (i.e., the IVDD or IVDR). The specific requirements for IVDs are detailed in the below table found in section 6 on page 16 of the information sheet.  This page also notes that only the name and address of the registered place of business for the Economic Operator (i.e., for the CH-REP) must be included.

    Swissmedic further defines a "document accompanying the device" on the same page as a document that "can be affixed to the device or be separate from the device. Examples of documents accompanying the device include: delivery note, guarantee certificate, customs documents, invoice, a sticker on the packaging or the instructions for use. Such documents must accompany the devices when they are placed on the market and through the supply chain so that distributors are able to fulfil their verification obligation stated in Art. 54 para. 1 let. d MedDO or Art. 47 para. 1 let. d IvDO (indicating the importer). Therefore, the "document accompanying the device" does not necessarily need to reach the end user."



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    Sydney O'Connell
    Director of Global Representation
    www.casusconsulting.com
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    Original Message


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