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  • 1.  MDR, GSPR 10.4 on substances

    Posted 21-Nov-2019 11:56
    Hi all,

    For EU MDR, we are reviewing even more in detail the GSPR 10.4.1 on substances. I have read all posts here on this subject. But I have a kind of wording question / English grammar. This because we have different interpretation internally.

    Here is the exact text of MDR, GSPR #10.4.1
    [...]

    Devices, or those parts thereof or those materials used therein that:

    • are invasive and come into direct contact with the human body,
    • (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
    • transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,
    shall only contain the following substances [...]
    ​​

    Do you understand it as this requirement concerns
     - devices that are 1 and (2 or 3) ? Meaning invasive devices in direct contact with body that either administer or transport /store .... to body
     - devices that are 1 or 2 or 3? Meaning invasive devices in direct contact with body OR devices that administer ... OR devices that transport /store .... to body

    In other words is the "or" applicable to all subsets or does it only concerns the 2 last subsets? Yes we could justify this internally if not clear but we would largely prefer to try to consider the current industry understanding upfront in order not to have to justify that to our notified body (or reduce the probability to have questions). And of course we cannot ask our notified body because it is not yet accredited....

    Sorry if my question seems silly.

    ------------------------------
    Maud Giorgi
    QMS & RA Manager
    Lausanne
    Switzerland
    ------------------------------


  • 2.  RE: MDR, GSPR 10.4 on substances

    Posted 21-Nov-2019 12:13
    Edited by Julie Omohundro 21-Nov-2019 20:38
    I would take it as 1 or 2 or 3.   That's because I would read it as a sentence that has been reformatted with bullets:

    Devices, or those parts thereof or those materials used therein that are invasive and come into direct contact with the human body; (re)administer medicines, body liquids or other substances, including gases, to/from the body; or transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body, shall only contain the following substances...

    I would also edit it, a practice it appears the EC has never embraced.  Among other things, I would not bold or underline the 'or,' because, when the text is converted to a sentence, I think the meaning is perfectly clear without bold or underline.  Moreover, I think emphasizing the 'or' gives the impression that it is being used in some way other than it would be used in a sentence, further suggesting that this text is not a sentence, and therefore cannot be read as a sentence, and thereby confusing things further.




    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: MDR, GSPR 10.4 on substances

    Posted 21-Nov-2019 15:21

    In American English the convention is that for a bulleted list with one "or" the disjunction applies to each item in the list separately. Also, the "or" is non-exclusive. Sometimes people this as "and/or".

    In this case the requirement applies if any one bullet is satisfied, any two, or all three.

    The EU-MDR is in British English (you can tell by the spellings), but I believe the same conventions apply.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 4.  RE: MDR, GSPR 10.4 on substances

    Posted 21-Nov-2019 18:12
    I'm just curious.

    Since you are in Switzerland, why does the English version matter?

    I would have expected that the EU-MDR in other languages would be more relevant.


    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 5.  RE: MDR, GSPR 10.4 on substances

    Posted 22-Nov-2019 03:02
    Hi all,

    I would read it as (1) or (2) or (3) as well.

    Dan, the MDR was originally written in English, and the translated to the other official EU-languages. The translation was done rather hasty. Thus, there are many deviations between the original English and the translations. During the first corrigendum, some translation errors were removed. If you want to be on the safe side, always refer to the English text. (At least check your translation in the points you discuss against it.)

    Regards,

    Britta

    ------------------------------
    Britta Cyron
    Bochum
    Germany
    ------------------------------

    Original Message


  • 6.  RE: MDR, GSPR 10.4 on substances

    Posted 22-Nov-2019 03:59
    Edited by Maud Giorgi 22-Nov-2019 04:00
    Hi,

    Good question. To be honest I never work in french. This because the original is English and errors can occur during translation. Occasionally I verify the french version but not in this instance... And all of our documentation is of course in English so we work with EN version of MDR.

    I read it now in French and in French there is "or" at each line. Which would mean that any of the bullet is to be considered. Which was also my interpretation of English. And is also for Italian native reading the Italian version.

    So to summarize, for me, this requirement means that we have to consider REACH / CLP as defined below in GSPR 10.4.1 chapter if any of the 3 bullet applies. In our cases, for few of our devices, the first bullet applies (being invasive and in direct contact with human body) so we will have to consider as applicable REACH / CLP requirements defined below in GSPR 10.4.1 chapter.

    Thanks all for your feedback.

    ------------------------------
    Maud Giorgi
    QMS & RA Manager
    Lausanne
    Switzerland
    ------------------------------

    Original Message


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