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  • 1.  IVD and lab equipment

    This message was posted by a user wishing to remain anonymous
    Posted 15-Mar-2023 09:42
    This message was posted by a user wishing to remain anonymous

    Hi everyone, 

    We are an IVD manufacturer based on EU. We have a contract with UK company to assembly (manufacture) a platform (reader) for us that we are planning to CE-mark it as an IVD. the contractor came back to us saying that they will be responsible about the device as a lab equipment only. I am not sure what they mean by this and whether this has an impact on our initial plan. 

    What i would like to know is what lab equipment clearance is and how this different from IVD. 

    your thoughts and input are appreciated. 

    Thanks. 



  • 2.  RE: IVD and lab equipment

    Posted 16-Mar-2023 06:52

    Hello Anon,

    There is a fine line between IVD instruments and lab equipment which in some cases could be either or both.  This really comes down to the claims which are being made for the device, what the device/equipment does, intended purpose, and maybe what step in IVD test processing is involved.  The Contract Manufacturer in UK are stating they will be responsible as lab equipment only because they do not want to take the regulatory responsibility (even through your company as the [legal] Manufacturer may take this) having the instrument or equipment classified as something else or a higher regulatory status.  Therefore, it would fall completely upon your company as the (legal) Manufacturer to take all responsibility including regulatory aspects and they would be in the position of "just" making a piece of lab equipment.  And the main reason is there is no "clearance" or approval of laboratory equipment.

    There may be specific safety tests which need to confirm, i.e. electrical safety, heating generation, moving parts, etc., but these would be regulated by different Directives, Regulations, or standards as only lab equipment.  Also as lab equipment, generally there is no type of regulatory review or approval which would be a passive process meaning if the laboratory equipment was sold and used routinely with no issues, nothing would arise - it would only be if there was a safety event(s) which other regulatory agencies may get involved.

    An easy example of an IVD device versus laboratory equipment would be a centrifuge.  If the company makes medical claims (IVD medical device claims) where the centrifuge processing is critical for the IVD test, then the centrifuge could be an IVD medical device.  Otherwise, a centrifuge would only be a piece of lab equipment.  However, the centrifuge as a lab equipment would still need to follow safety regulations, e.g. impact resistant internal container, impact lid, safety interlocks, etc., but again these would be managed by different regulations or standards.  If the centrifuge was an IVD medical device it typically would comply with all the safety items, in addition the performance of the instrument as part of the IVD test.



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

    Original Message


  • 3.  RE: IVD and lab equipment

    This message was posted by a user wishing to remain anonymous
    Posted 20-Mar-2023 08:38
    This message was posted by a user wishing to remain anonymous

    @Richard Vincins Thank you very much for taking time to reply. 

    in the example you gave, centrifuge, how will this be placed in the EU-market as a piece of  equipment with CE-MARK? i.e., what is the process for fixing CE in this case? 

    Thanks. 


    Original Message


  • 4.  RE: IVD and lab equipment

    Posted 16-Mar-2023 10:11

    Hi,

    LDT (Lab developed tests) requirements are very much lesser when compared to a IVDR product. The manufacturer would need to provide scientific evidence demonstrating the safety and performance of the LDT, and comply with the IVDR's requirements for clinical evaluation, labeling, and post-market surveillance. The manufacturer may also need to make changes to the LDT design, manufacturing processes, and quality control procedures to meet the regulatory requirements.



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 5.  RE: IVD and lab equipment

    Posted 20-Mar-2023 10:52

    Anon,

    A piece of lab equipment may have other Directives or Regulations which apply which are more related to safety and compatibility, such as Low Voltage Directive (LVD) or specific standards which may apply, e.g. ISO or ASTM standards.



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

    Original Message


  • 6.  RE: IVD and lab equipment

    This message was posted by a user wishing to remain anonymous
    Posted 20-Mar-2023 11:38
    This message was posted by a user wishing to remain anonymous

    Thank you guys for your responses. Really helpful. 


    Original Message


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