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  • 1.  CE-marking for lab equipment

    This message was posted by a user wishing to remain anonymous
    Posted 25-Apr-2023 08:18
    This message was posted by a user wishing to remain anonymous

    Hi all, 

    Does any one know what regulations/ directives and standards that we need to comply with to CE-mark a fluorometre (cassette reader) as a lab equipment. 

    Thanks. 



  • 2.  RE: CE-marking for lab equipment

    Posted 25-Apr-2023 20:33

    Hi Anon

    You might begin with the list of CE-marking legislation here: https://single-market-economy.ec.europa.eu/single-market/ce-marking/manufacturers_en

    Depending on the design of the thing, you might need the EMC, Low Voltage, Measuring, and Restricted Substances rules. Beyond the CE-marking rules, of course there are other potentially applicable rules, again depending on the design details (REACH, Packaging, Batteries, etc.)



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: CE-marking for lab equipment

    Posted 26-Apr-2023 10:48

    Hello Anon,

    If the cassette reader is being positioned as NOT an IVD medical device/medical device but only as general laboratory equipment, Anne already mentioned a few Directives/Regulations which may be applicable.  It depends on the exact positioning of the device in the market and as electronic equipment, there may be additional local requirements which need to be met, e.g. WEEE.  If the product is brought under the EU IVDR as say a Class A laboratory equipment, the IVDR needs to be met, but some of those other regulations also may need to be met.  Might want to seek some further guidance because depending on the product there can be quite a number of Directives/Regulations which are needed for compliance.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: CE-marking for lab equipment

    Posted 27-Apr-2023 03:26

    Start with the IVDR and decide on your intended purpose. Is that clinical (i.e. testing of patient samples or not)? If yes, congratulations: you have an IVD as Richard observed), likely class A (depends on the intended purpose though) under the IVDR. IVDR rules apply which contain all the rules re electrical safety and such that Anne mentioned.
    If it is general lab equipment or RUO (i.e. not clinical - don't assume that too easily) then it's not an IVD and the regulations that Anne mentioned apply because it's electronic equipment.
    The exact standards that apply will be those harmonisd under the specific essentail requirement / general safety and performance requirement of the applicable regulation or directive: if IVDR, all in one place; if not IVDR on a per directive/regulation basis.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


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