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RoHS 2( 2011/65/EU) Lab instrument compliance date?

Discussion in 'EU Medical Device Regulations' started by QAengineer13, Apr 22, 2016.

  1. QAengineer13

    QAengineer13 Member

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    RoHS 2 compliance for IVD research only use device , what is the compliance date and where can I find this information (FYI this IVD research unit does not fall under Business-to-business model, it falls under Laboratory instrument) I am unable to find the source for compliance date of RoHS 2 for Lab instruments, any help will be very much appreciated!
     
  2. Pads38

    Pads38 Member

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    Transition: Devices must bear a CE mark and have a declaration of conformity for the RoHS Directive from
    • 22 July 2014 for Medical Devices.
    • 22 July 2016 for In-Vitro Diagnostic Medical Devices
    Source:
    http://www.mddionline.com/blog/devicetalk/rohs-recast-implications-eu-med-ivd-devices

    See also Article 4(3) of RoSH2.

    But there is also a date of 22 July 2019 given in Article 2(2) - I am not clear of how that changes things.

    RoSH2:
    http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32011L0065
     
    Last edited: Apr 22, 2016
  3. QAengineer13

    QAengineer13 Member

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    Thanks Pad for the info, I am aware of the Medical Deivce and IVD RoHS, my question is more focused on the RESEARCH USE ONLY - IVD, any input will be greatly appreciated!
     
  4. Monica

    Monica New Member

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    RoHS is an environmental directive: even if research use only, the device still remains an electric/electronic equipment and there is no difference in its management at the end of its useful life. I think that "research only" could only worsen the matter: if you don't use it for clinic, there is no risk for the patient deriving from not validated components or manufacturing process , which was the main reason for excluding MD/IVD from RoHS1. so, I don't think the "research use only" can make a difference, except for the initial statement about business-to-business .
     

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