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  • 1.  Guidance on Hazardous Substances - EU MDR 2017/745

    Posted 22-Jul-2021 11:06
    Hello! I am hoping to receive any recommendations on guidances or resources related to hazardous substances per EU MDR. In the MedTech Europe guidance, "Use of Symbols to Indicate Compliance with the MDR", there is mention of another guidance, "MDR Requirements on Hazardous Substances". I cannot locate this document in the online MedTech Europe Resource Library – assuming that is because I am not a member (This guidance is internal and available to MedTech Europe members only).

    Does anyone have a copy of this specific MedTech Europe guidance ("MDR Requirements on Hazardous Substances") that they could share?

    Or are there any other relevant resources you may have found to be helpful in preparing for compliance with EU MDR for any devices requiring such labeling and justification?

    Subject matter would tie to EU MDR 2017/745, Annex I, Chapter II, specifically pertaining to:
    • § 10.4.1, Design and manufacture of devices → Substances which are carcinogenic, mutagenic or toxic to reproduction ('CMR'), with reference to Regulation EC No. 1272/2008.
    • and/or § 10.4.5, Labelling.


    Thank you so much in advance,

    Victoria Dahlen
    Quality Engineer II



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    Victoria Dahlen
    Quality Engineer II
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  • 2.  RE: Guidance on Hazardous Substances - EU MDR 2017/745

    This message was posted by a user wishing to remain anonymous
    Posted 04-Aug-2021 13:33
      |   view attached
    This message was posted by a user wishing to remain anonymous

    Hello Victoria,

    I have this release, I am not sure that is the last version but I share it with you.

    Best regards

    Attachment(s)

    pdf
    MDR hazardous substances requirements (v2.0).pdf   1.41 MB 1 version
    Original Message


  • 3.  RE: Guidance on Hazardous Substances - EU MDR 2017/745

    Posted 27-Aug-2021 12:02
    I apologize for the delay, I am just seeing this response. Thank you so much for taking the time to provide a version of this guidance document! It will be of great use to us to review for compliance.

    Best regards,

    ------------------------------
    Victoria Dahlen
    Quality Engineer II
    CIVCO Medical Solutions, Inc.
    Coralville, IA
    USA
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    Original Message


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