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  • 1.  Conformity declaration IVD

    Posted 03-Jun-2016 09:17

    Hello,

     

    We like to create a conformity declaration for an IVD. Not only IVD directive applies, but also EMC and low voltage. Do I have to list all of these directives on the DoC? Or does IVD supersedes the others?

     

    Thanks a lot for help!

     

    Jana


    Sysmex Partec is an ISO 9001:2008 and ISO 13485:2012 certified company

    Sysmex Partec GmbH, Am Flugplatz 13, 02828 Goerlitz, Germany
    Web: www.sysmex-partec.com E-Mail: info@sysmex-partec.com
    Company location: Goerlitz, Registered AG Dresden, HRB 18508, VAT-ID: DE 209 298 480
    Managing Directors: Shinjiro Akamatsu, Matthias Guhl, Dr Michael Schaefer, Takeshi Kubota, Mitsuru Watanabe, Takashi Ono

    This e-mail may contain confidential and/or privileged information. If you are not the intended recipient (or have received this e-mail in error) please notify the sender immediately and delete this e-mail. Any unauthorized copying, disclosure or distribution of the material in this e-mail is strictly forbidden.


  • 2.  RE: Conformity declaration IVD

    Posted 04-Jun-2016 07:52

    Hello Jena

    You could list these all but check the IVD directive to see of presumption of conformity with that assumes conformity with all others which must be considered, including EMC, Low Voltage, (Battery if you have a backup) and ROHS2.    Also remember to have in your files an analysis of applicability of the Machinery Directive (probably not applicable).

    Most of these others can be encompassed under the single DoC for IVD (under the old directive) but check wording under the new MDD now. ROHS2 specifically requires its own DOC or to be called out on the DOC.

    Good luck!

    Ginger Cantor, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    715-426-3472




    Original Message


  • 3.  RE: Conformity declaration IVD

    Posted 05-Jun-2016 15:39

    Hi Jana,

    Yes, you should include relevant Electrical Safety,Low Voltage and EMC Directives/Standards in addition to other Harmonized standards (for labeling, software etc., etc.) as appropriate.

    Thanks

    Sarah Glover

    Regulatory Affairs Consultant

    IVDs/MDs

    ------------------------------
    Sarah Glover
    Ambler PA
    United States

    Original Message


  • 4.  RE: Conformity declaration IVD

    Posted 05-Jun-2016 19:10

    Refer to the EC Blue Guide, section 4.4 @ http://ec.europa.eu/DocsRoom/documents/16210, which states "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." And "The single declaration of conformity can be made up of a dossier containing all relevant individual declarations of conformity."

    Are you sure 2014/35/EU LVD applies? Annex II states electrical equipment for radiology and medical purposes is outside the scope of the LVD, and 98/79/EC IVDD defines an IVD as an in vitro medical device and as such it has to have a medical purpose.

    ------------------------------
    Craig Ethen
    Regulatory Affairs
    Portland OR
    United States

    Original Message


  • 5.  RE: Conformity declaration IVD

    Posted 06-Jun-2016 06:10

    Great, thanks to you both for your helpful feedback.

     

    Jana


    Sysmex Partec is an ISO 9001:2008 and ISO 13485:2012 certified company

    Sysmex Partec GmbH, Am Flugplatz 13, 02828 Goerlitz, Germany
    Web: www.sysmex-partec.com E-Mail: info@sysmex-partec.com
    Company location: Goerlitz, Registered AG Dresden, HRB 18508, VAT-ID: DE 209 298 480
    Managing Directors: Shinjiro Akamatsu, Matthias Guhl, Dr Michael Schaefer, Takeshi Kubota, Mitsuru Watanabe, Takashi Ono

    This e-mail may contain confidential and/or privileged information. If you are not the intended recipient (or have received this e-mail in error) please notify the sender immediately and delete this e-mail. Any unauthorized copying, disclosure or distribution of the material in this e-mail is strictly forbidden.



    Original Message