Chris P Created: Jul 11, 2022 Last commented: Jul 15, 2022

Swiss Notified Bodies

Hello Sorry if this is in the wrong category. My Swiss supplier uses a Swiss notifed body for their ISO and CE. I beleive Swiss notified bodies are no longer accepted in the EU. The same applies in the UK from what I have been told. When I asked my supplier, they said comapnies in Europe are still purchasing from them. I do not dount they are telling me the truth. But this cannot be correct as it is not MDR compliant is it? So I would be correct to stop selling the product? Thanks

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Kristina Zvonar Brkić Jul 14, 2022

Medical devices that still have a valid MDD certificate from the Swiss notify body can be on the market as long as the MDD certificate is valid. When it expires, so far Swiss notify bodies are not allowed to give MDR certificates.

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Chris P Jul 14, 2022

Thank you for the reply. The supplier I am referring to have a valid CE and DOC for the class IIA products which is under MDD. The DOC for the class I product is under MDR. Does this mean they can sell the Class IIA bit not the the class I?

Sorry for all the questions, I just want to make sure I am following the correct rules

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Kristina Zvonar Brkić Jul 15, 2022

No, it means that you can sell all products. Class I must be in compliance with the MDR from May 2021. So, you have a very good client that follows everything necessary.

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Jul 11, 2022

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