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  • 1.  DoC update under soft transition

    This message was posted by a user wishing to remain anonymous
    Posted 27-Nov-2019 11:44
    This message was posted by a user wishing to remain anonymous

    Hi Guys,

    Just wondering if there is a need to update the DoC template and the DoC if undergoing soft transition as per EU-MDR to say that in addition to MDD Directive --- we also comply with Article 120 of the EU-MDR.

    Any thoughts?

    Thanks!


  • 2.  RE: DoC update under soft transition

    Posted 27-Nov-2019 12:20

    You do not need to update your DoC. Under the Article 120 transition the device remains under the MDD requirements.

    There is an interesting issue that I recently learned about. I'm working with a client on the DoC under the MDD; they apply RoHS and the EMC directive. As we were researching the requirements, we found a requirement for a one DoC that covers all the directives or regulations that apply. Currently, they make separate DoCs. The requirement is not in the MDD. Check any other directives that apply to your device.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: DoC update under soft transition

    Posted 28-Nov-2019 05:15
    Just a comment on "the DoC under the MDD; they apply RoHS and the EMC directive".

    The EMC Directive is non-applicable to medical devices within the scope of the MDD (93/42/EEC), because the MDD includes its own essential requirements for EMC.

    The Blue Guide states:

    "Certain Union harmonisation acts exclude from their scope products covered by other acts or incorporate the essential requirements of other acts which avoids simultaneous application of redundant requirements. In other instances, this is not the case and the general principle of simultaneous application still applies where the requirements of the Union harmonisation acts are complementary to each other."

    While EMC is covered in the MDD, RoHS is not, hence a Declaration of Conformity to RoHS is required together with the MDD DoC, but not for EMC.

    This is reflected in the MDD introductory 'Whereas' section, in which it states:

    "Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility."

    And also in MDD Article 1(7), which reads:

    "This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council."

    I hope this clarifies the issue with regard to MDD and EMCD.

    ------------------------------
    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
    ------------------------------

    Original Message


  • 4.  RE: DoC update under soft transition

    Posted 28-Nov-2019 07:33
    Hi Dan

    I had the same issue when I was at 3M.  may come from a MEDDEV too  But it does show up in electrically related Directives.  And various NB auditors at both BSI and TUV SUD asked for it.

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 5.  RE: DoC update under soft transition

    Posted 29-Nov-2019 04:32
    Edited by Maud Giorgi 29-Nov-2019 04:34
    Hi all,

    I confirm that you should have one EU DoC (or compilation of) for all directives that applies to a product. For MD, it could be MDD (/MDR) and RoHS and RED, ...

    This was said by our notified body and by German Authority when auditing our products (documentation perspective). And this come from the blue guide by the way.
    "A single declaration of conformity is required whenever a product is covered by several pieces of Union harmonisation legislation requiring an EU declaration of conformity. The single declaration of conformity can be made up of a dossier containing all relevant individual declarations of conformity."

    We chose to have 1 for all but the wording is important as for some directive notified body is not involved. So this has to be clear in it to which directive the notified body is involved. Both our notified body and German Authority where ok with the approach.

    For MDR, I will look again at blue guide as there are chapters about having multiple directive / regulation during transition (it was written at the moment of transition from "old" to "new" directives). I will see how it applies (or not) to MDD / MDR switch...


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    Maud Giorgi
    QMS & RA Manager
    Lausanne
    Switzerland
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    Original Message


  • 6.  RE: DoC update under soft transition

    Posted 29-Nov-2019 06:10
    I can confirm what Maud had said about having one versus multiple DofCs - need to work with the Notified Body and any local authorities.  Generally, you should be able to have declaration to all applicable Directives, Regulations, and/or standards on one DofC, though as mentioned may need to be worded properly.  It also generally depends on the device type as well - which is usually consistent with which other Directives or Regulations need to be stated for declaration, i.e. PPE or RoHS.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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