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  • 1.  Gap Analysis Between MDD and MDR

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2019 09:40
    This message was posted by a user wishing to remain anonymous

    Hello All,

    Can you please share some of the most useful reference/guidance that you have found with regards to the differences between the MDD and MDR and those references/guidances that aid manufacturers in providing a gap analysis? A good example of the type of document I'm talking about is CEN/TR 17223:2018. 

    Thank you in advance!


  • 2.  RE: Gap Analysis Between MDD and MDR

    Posted 20-Jul-2019 12:46
    Unfortunately the amount of differences between MDD and MDR compliance is quite significant much greater than can be listed on this thread.  CEN/TR 17223:2018 is helpful but it really only addresses Article 10 - there is much more to the MDR such as Annex I, II, III, XIV, articles on post market, etc.  We have developed a tool today stands around 100 line items we check for compliance to MDR, in comparison to our MDD tool that had about 25 line items.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Gap Analysis Between MDD and MDR

    Posted 21-Jul-2019 07:02
    Hi Richard
    as you mentioned in you response  

    We have developed a tool today stands around 100 line items we check for compliance to MDR, in comparison to our MDD tool that had about 25 line items.
    Does s it possible to receive or buy this tool?

    Evangelos
    Prague
    CZ


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    Evangelos Tavandzis
    Lead Auditor, Consultant
    Praha
    Czech Republic
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  • 4.  RE: Gap Analysis Between MDD and MDR

    Posted 21-Jul-2019 08:14
    Richard,

    Is your tool available for purchase? I am looking for something suitably easy.  The last tool I purchased was a bear to use..

    If so, can you provide a link?

    Thanks,

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



  • 5.  RE: Gap Analysis Between MDD and MDR

    Posted 21-Jul-2019 08:14
    Richard,

    Is your tool available for purchase? I am looking for something suitably easy.  The last tool I purchased was a bear to use..

    If so, can you provide a link?

    Thanks,

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



  • 6.  RE: Gap Analysis Between MDD and MDR

    Posted 22-Jul-2019 02:02
    Sorry this is not available for purchase; we use our internally developed tool to perform baseline, assessment, and pre-assessment audits of companies so it is not a "stand alone" type of product or document we can make available. With the intricacies of how the EU MDR relates to the quality system was pointing out to Anon there are quite a few differences, and we personally treat an EU MDR assessment as a brand new view.  We perform a gap assessment against the EU MDR, we do not perform a gap assessment against the what may have been existing with the EU MDD.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 7.  RE: Gap Analysis Between MDD and MDR

    Posted 23-Jul-2019 18:15
    Hello, Anon---

    I came across this on LinkedIn: https://www.regulatoryglobe.com/shop/mdr/mdd-vs-mdr-gap-assessment-tool/

    There is a free version (you have to click the button, and it asks for some info) I can't vouch for this, but it was shared by some people that I admire. 
    Hopefully, it helps

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    Kimberly Parker Howard
    Ventura, CA
    www.linkedin.com/in/kparkerhoward
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  • 8.  RE: Gap Analysis Between MDD and MDR

    Posted 25-Jul-2019 04:09
    I have to second Richard, in the end you are not interested in the gap between the MDD and MDR for future compliance, but you are interested in the gap of your QMS, Technical Documentation, arrangements and contracts with the other Economic Operators and other documentation with the applicable requirements ​of the MDR.
    Although there seems to be a common assumption that the MDR is a kind of a MDD+ (meaning that there are only new, additional and changed requirements and no contradictory requirements in the MDR) the changed structure makes it virtually impossible to do a 1-on-1 comparison of the requirements.
    And as last argument, focussing on the gap between the MDD and MDR also assumes that your current documentation is completely MDD compliant and we all know that that is not always the case.....

    So the best approach seems to be to read and understand the whole (..) thing and draw your conclusions. Your obtained MDR expertise will be valuable.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
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