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  • 1.  IVDR and CE Certificate

    This message was posted by a user wishing to remain anonymous
    Posted 11-Feb-2020 17:04
    This message was posted by a user wishing to remain anonymous

    Hi,
    Will Notified Bodies issue a CE Certificate for IVD products after implementation of the IVDR?
    Thank you


  • 2.  RE: IVDR and CE Certificate

    Posted 12-Feb-2020 04:41
    Hello,

    They can issue CE Certificates to the EU IVDR as soon as they are designated, they do not need to wait until May 2022 for the compliance date.  Because the EU IVDR is already "in force" then this can be applied.  However, only Notified Bodies designated to the EU IVDR may audit or issue certificates against the new regulation.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: IVDR and CE Certificate

    Posted 12-Feb-2020 05:25
    Hi 
    It depends what the classification of the IVD will be under the IVDR.

    But as most of the IVDS have to go for up classification (from IVDD to IVDR: around 85% have up-classification) then indeed those products needs to be reviewed/ audited and controlled by a notified body designated for the relevant NBOG codes under the IVDR. For all Class A sterile products, Class B, Class C and Class D the notified body will issue a CE certificate only after approval of the complete technical documentation and that the Annex IX audit was satisfactorily executed with no non-conformities. only Class A products will remain self-declared and no CE certs are issued.
    Therefore all IVDS with upclassificiltion from self-declared to Class B, C and D (and Class A sterile) need an CE cert issued by a designated Notified body as of 26 May 2022. Just for your information;: estimated time to get approval is around 9 to 12 months. So better to get the files and QMS ready by Q1 2021, and that the notified body can start the work: So still one year to go...... 

    Kind regards

    Anja Wiersma

    Chair of the Board of RAPS Netherlands Chapter

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    Anja Wiersma
    Chair of Board of RAPS Netherlands Chapter, CEO of mi-CE consultancy
    Valburg
    Netherlands
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    Original Message


  • 4.  RE: IVDR and CE Certificate

    Posted 13-Feb-2020 02:58
    HI 

    Just another remark after my response yesterday on CE IVD's. Now about the LDT/ In House developed test (so no CE-IVDs)

    When you are talking about LDT's or in -house developed tests (as we call them in Europe now): the in-house developed test have to comply to Article 5.5 of the IVDR and although it is just one part of a small article it is crucial and may turn the laboratorium and LDT- in house developed tests all around. 

    It described that only LDT's are allowed of no CE IVD is available ; and then you have to all those LDT test publicly available. It should not be an test produced soon an industrial scale.. ets..Please read article 5.5 in depth to understand the requirements.
     And LDT's In house developed tests have to comply to Annex I of the IVDR (General Safety and Performance requirements), which is all. 

    The notified bodies are not involved in the control on this: it is the Competent Authorities who are controlling if the labs are indeed in compliance with IVDR article 5.5.
    They may issue warnings and afterwards a big fine (around 650.000 Euro) if your lab is not complying to the requirements of the IVDR.

    I just wanted to inform you about this new requirement regarding in House developed test /LDT as described in the IVDR.

    Kind regards

    Anja Wiersma

    ------------------------------
    Anja Wiersma
    Chair of Board of RAPS Netherlands Chapter, CEO of mi-CE consultancy
    Valburg
    Netherlands
    ------------------------------

    Original Message


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