Regulatory Open Forum

 View Only

  • 1.  Switzerland

    Posted 11-Jun-2021 11:27
    Regarding the Swiss medical device market, what is the current outlook regarding the regulatory landscape there short and long term? From my brief research it seems unclear.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------


  • 2.  RE: Switzerland

    Posted 12-Jun-2021 11:45
    Dear Ed

    Since the Mutual Recognition Agreement between the EU and Switzerland was not renewed, Switzerland is now considered a third country, although the MDR was transposed into the Swiss Medical Device Ordinance (law). Consequently, Swiss manufacturers now need an Authorized Representative located in the EU and manufacturers outside of Switzerland require an Authorized Representative located on Switzerland. There is a transition period for the Swiss Authorized Representative, it must be nominated latest by:

    - 31 December 2021: class II and IIb implantable devices
    - 31 March 2022: not implantable class IIb devices, class IIa devices
    - 31 July 2022: class I devices, systems, and procedure packs

    If a manufacturer may legally place products on the market in Europe (based on an CE certificate issued by a designated Notified Body) those devices may also be placed on the market in Switzerland.

    The parties are still negotiating "behind the scenes" but imho there is little hope that it get significantly better.

    Please let me know if you have additional questions.

    Cheers, Beat

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

    Original Message


  • 3.  RE: Switzerland

    Posted 12-Jun-2021 12:58
    Good morning,

    I found this information very useful but for my understanding this deadlines are applicable for legacy medical devices (MDD).

    For all MDR products, economic operators must register within three months of placing their first (MDR) product on the Swiss market.

    Importer needs to identify itself on the device, its packaging, or in a "document accompanying the device".

    Documents such as the commercial invoice or other shipping documents would be sufficient?

    Thank you in advance

    K

    ---------------------------------
    Katarzyna Chrusciel
    Engineer

    Italy
    ---------------------------------



    Original Message


  • 4.  RE: Switzerland

    Posted 14-Jun-2021 00:17
    Dear Katarzyna

    Many thanks for your reply. There is indeed something which requires interpretation in the Swiss MedDO. Article 55 requires economic operators (manufacturers, representatives and importers) to register with Swissmedic latest 3 months after the first placing on the market. I see this as a general requirement and is applicable regardless of whether it's an MDD or MDR CE marked medical device.

    Article 104a defines transition periods for nominating a Swiss representative (BTW: if you require this service - pls get back to me, we offer it). Nothing in this article mentions the MDD, it just mentions "placing on the market after 26 May 2021". Imho this prevails over Article 55 because it's explicit compared to a more general requirement. 

    Cheers, Beat

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

    Original Message


  • 5.  RE: Switzerland

    Posted 14-Jun-2021 08:40
    Also note the one Swiss NB which did not get designated to EU MDR would no longer be used for CE Marking - kind of mute point since they did not get designated.  However, use caution if you have 1250 Notified Body for legacy devices under the MDD as no changes most likely would be allowed.

    I find it interesting in the long term, we might have more "third country" in Europe than the Commission would hope or like.  At least the regulatory world we are used to having Sponsors or Representatives in different countries.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 6.  RE: Switzerland

    Posted 14-Jun-2021 09:27
    Dear Richard

    As a Lead Auditor and product reviewer of SQS (CE 1250) the decision of the EC commission to no longer accept CE certificates issued under the MDD after the DoA according to Article 120 of the MDR was / is hard to digest. This particularly because the reason is solely a political one. On the other hand (and very interestingly) one also has to say that this was a statement and not an act. The Swiss governement is still of the opinion, that these certificates are covered, because they were issued under the MDD. However, some problems regarding importation of medical devices to the EU were reported so are real.

    Regarding changes: as you know, no significant changes may be introced anyway after the DoA, regardless of the Notified Body. The definition of "significant change" is defined in MDCG-2020-3.

    Cheers, Beat

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

    Original Message


  • 7.  RE: Switzerland

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2021 08:41
    This message was posted by a user wishing to remain anonymous

    Dear Beat,

    This information is quite useful, many thanks. My understanding is that if a non-Swiss EU based manufacturer places MDR products on the Swiss market, the Swiss importer needs to be registered with Swissmedic in three months. Do labels need to be updated to include importer name and address within the same 3 month period?

    Thanks.
    Original Message


Related Content