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medical device conformity assessment procedure for Switzerland only (lack of CE-certificate)

  • 1.  medical device conformity assessment procedure for Switzerland only (lack of CE-certificate)

    Posted 04-Feb-2022 06:15

    Dear Swiss Medical Device Experts,

     

    could you please help me by letting me know your advice.

    My understanding is, that according to the MedDO in case a Swiss medical device manufacturer intends to market a medical device in Switzerland but does not have valid CE-certificate of it,

    • it may apply for a local conformity assessment by SQS,
    • if that is successfully passed,
    • in the possession of the MD conformity marking and after the completion of the Swiss registration process
    • the device may be marketed in Switzerland.

     

    I have found the scope of designation of SQS here Designated bodies (swissmedic.ch)

     

    What to be done, if the concerned therapeutic area is beyond the scope of SQS's designation?

     

    Thank you for your help ahead, with best regards



    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------


  • 2.  RE: medical device conformity assessment procedure for Switzerland only (lack of CE-certificate)

    Posted 05-Feb-2022 09:07
    Dear Peter,
    A very interesting question. So far as you mentioned the
    Swiss conformity marking according MedDO Annex 5 is attached if a device is only placed in the Swiss market.
    In your case described there are two ways:
    a) Swissmedic recognizes conformity procedures of European Notified Bodies. Thus, the manufacturer can search SQS and any NB in the NANDO with a scope suitable to the medical device, the Conformity assessment procedures required are described in MDR Art 52 - see MedDO Art 23.  According MedDO Art 13 the manufacturer has to label with the Swiss conformity marking - or CE which is excluded in your case described.
    b) Another possibility would be MedDO Article 22 Exemptions, which is a possibility in certain circumstances. If Swissmedic authorizes the placing on the market and putting into service of a specific device there are acc. SR 812.214.5 fees of CHF 1000.- for each authorization.
    Hope this helps.
    Best regards
    Margit

    ------------------------------
    Margit Widmann MD
    Director Regulatory
    Günsberg
    Switzerland
    ------------------------------

    Original Message


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