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Swiss law for medical devices

  • 1.  Swiss law for medical devices

    Posted 26-May-2021 19:18

    Hi,

     

    Are the Swiss laws for medical devices already effective ? What are the mandates for the non-EU manufacturers?

     

     

    Thanks & Regards,

    signature_1537400070

    Rashmi Pillay

    Regulatory Affairs Manager

    Ellex – Lumibird Medical group

    3-4 Second Ave, Mawson Lakes SA 5095
    Tel. +61 8 7074 8105

    Email rpillay@ellex.com

     

     

     

     

     

     

     

     

     

     

     

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  • 2.  RE: Swiss law for medical devices

    Posted 27-May-2021 02:24
    Edited by Joël Kler 27-May-2021 02:25
    Hi,

    Yes, it's effective since yesterday, the "D-Day", and you can find it here, but only in the official languages of the Confederation : RO 2020 2977 - Ordonnance sur les dispositifs médicaux (ODim) (admin.ch), means in French, German & Italian, but I'm quiet sure that an non official translation should exist, I will try to find it.
    Because now Switzerland is considered as a 3rd country, companies who wants to make business with Swistzerland need a Swiss Representative, but the official law is basically build on the MDR 2017/745.

    ------------------------------
    Joël Kler
    Regulatory Affairs & Quality Manager
    Sonceboz
    Switzerland
    ------------------------------



  • 3.  RE: Swiss law for medical devices

    Posted 27-May-2021 02:57
    From which date shall EU manufacturers nominate a Swiss Representative?
    The device shall be also labeled with this information?

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    Andrea Duca
    COSMED Srl
    Albano Laziale
    Italy
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  • 4.  RE: Swiss law for medical devices

    Posted 27-May-2021 05:38
    There is a class based schedule for that, I will try to find the detail and post it here

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    Joël Kler
    Regulatory Affairs & Quality Manager
    Sonceboz
    Switzerland
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  • 5.  RE: Swiss law for medical devices

    Posted 28-May-2021 03:10
    Dear Andrea

    There is a transition phase till when you need a Swiss AR depending on your MD class. You can find the dates in Art. 104a of the MedDO (see link from Joël, on the website you can change the language to Italian). 


    ------------------------------
    Nicole Gabathuler
    Confinis AG - Enterprise
    Oberkirch
    Switzerland
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  • 6.  RE: Swiss law for medical devices

    Posted 28-May-2021 07:27
    Thanks Nicole ! Time was missing on my site to find it.

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    Joël Kler
    Regulatory Affairs & Quality Manager
    Sonceboz
    Switzerland
    ------------------------------



  • 7.  RE: Swiss law for medical devices

    Posted 29-May-2021 01:56

    Hi Nicole ,

     

    Art 104 seems to include  timelines for affixing UDI and not relevant for appointment of Swiss AR

     

    Thanks,

     

    ......................................................

    Rashmi Pillay

    T  +61 8 7074 8105

    E  rpillay@ellex.com

     

     






  • 8.  RE: Swiss law for medical devices

    Posted 27-May-2021 07:23
    Good Day Rashmi,

    I just read an article provided by Emergo on this topic.  You have to have a Switzerland AR as of yesterday to sell as they are now a "third country".  Here is the link to the article:  Placing medical devices on the Swiss market after the EU MDR Date of Application

    Best regards,

    ------------------------------
    D Michelle Williams
    VP - Operations
    United States
    ------------------------------



  • 9.  RE: Swiss law for medical devices

    Posted 27-May-2021 19:32
    Can somebody confirm, this is  required for legacy devices too, as mentioned in the  Emergo article , as the  MRA is not in place with the EU MDR , does it mean under the MDD , we could still supply without the Swiss AR?

    Regards ,

    Rashmi

    ------------------------------
    Rashmi
    ------------------------------



  • 10.  RE: Swiss law for medical devices

    Posted 28-May-2021 07:26
    Dear Rashmi,

    the Art. 100 looks interesting for you :

    Art. 100 Validity of certificates issued under the old law
    1 Certificates issued before 25 May 2017 under the old law shall remain valid until the expiry date indicated in the document, but no later than 26
    May 2022.
    2 Certificates issued on or after 25 May 2017 under the old law shall remain valid until the expiry date specified in the document, but not later than
    26 May 2024.

    ------------------------------
    Joël Kler
    Regulatory Affairs & Quality Manager
    Sonceboz
    Switzerland
    ------------------------------



  • 11.  RE: Swiss law for medical devices

    This message was posted by a user wishing to remain anonymous
    Posted 28-May-2021 09:30
    This message was posted by a user wishing to remain anonymous

    I think not:
    Swiss manufacturers will be treated like any other non-EU entities, and non-Swiss manufacturers will have to appoint Swiss Authorized Representatives (ARs) and importers based in Switzerland. This change affects all devices, including so-called "legacy devices," which rely on the prior Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to maintain their certificates for some time longer. 

    Maybe you can still make them available to the market (distribute them when they are already imported) but no longer "put on the market" (sell and import them) without SwissAR.


  • 12.  RE: Swiss law for medical devices

    Posted 31-May-2021 04:36
    Hi Everyone,
    This is the best source of information: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue-regulierug-mep-26-05-2021.html
    It has English version and contains links to registration forms (PDF with language selection)
    This is my interpretation of the information:
    • Economic operators (manufacturers, importers and authorised representatives) must register with Swissmedic and obtain a unique identification number ("Swiss Single Registration Number" CHRN). Swissmedic is already able to issue CHRNs as of 26 May 2021.
    • Economic operators must register within three months of placing their first (MDR) product on the Swiss market. 
    • Art. 104b MedDO requires economic operators who had already placed their products on the market prior to 26 May 2021 in accordance with Art. 22a MedDO of 17 October 2001 (MDD) to meet the following deadlines to register in accordance with Art. 55 para. 1 and 5 MedDO:
      • 1st 26 September 2021 for Class III products, Class IIb implantable products and all active implantable medical devices.
      • 2nd 26 January 2022 for non-implantable Class IIb products and all Class IIa products
      • 3rd 26 May 2022 for Class I products and systems and treatment units
    Regards

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    John Gibbs
    Agfa NV
    Mortsel
    Belgium
    ------------------------------