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  • 1.  Declaration of Conformity- EU MDR

    Posted 20-Mar-2020 17:42
    Hello all,

    I have a concern regarding EU MDR Declaration of Conformity (DoC). I am aware of the fact that DoC needs to be in draft state for class III devices until we obtain an approval from the EU notified body. However, I am not sure if the same is applicable for EU MDR class I and II devices as well.

    Any thoughts?

    Regards,
    Shikha

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    Shikha Malik
    United States
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  • 2.  RE: Declaration of Conformity- EU MDR

    Posted 21-Mar-2020 04:44
    Hi Shikha
    According to MDR, the manufacturer must prepare DoC for all Class I, IIa, IIb and III medical devices to my knowledge.

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    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
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    Original Message


  • 3.  RE: Declaration of Conformity- EU MDR

    Posted 21-Mar-2020 06:25
    To answer Shikha's specific question, the requirement for a draft of the DoC to be provided to your NB as part of the documentation included in the NB application applies to devices for which the Annex IX conformity assessment procedure is selected (full QMS route), per Annex IX(2.1 4th indent), together with those for which the Annex XI Part A conformity assessment route (production QMS route) has been selected, per Annex XI(6.1 1st indent).

    This requirement is therefore based more on the selected conformity assessment route for the device concerned, rather than its classification, although the two are obviously linked.

    Hope this helps.

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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Clinical Studies - Regulatory - Quality Systems
    Rome, Italy
    +39 06 578 2665
    rgray@donawa.com
    www.donawa.com
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    Original Message


  • 4.  RE: Declaration of Conformity- EU MDR

    Posted 22-Mar-2020 14:12
    You would have a "final" draft Declaration of Conformity ready during the Technical Documentation review.  Basically it should be at the point where it just needs to be signed and dated - everything else should be complete.  And yes, it would apply to all medical devices reviewed by a Notified Body.  Some Notified Bodies may request the DofC in a standardised format they use to help them ensure the content is same across all manufacturers; you should check with your individual Notified Body.  For Class I, self-declare devices you would just prepare the Declaration of Conformity to EU MDR Annex IV with any additional information as needed.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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