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  • 1.  Standards to satisfy Essential Requirements Sections

    Posted 31-Oct-2014 11:40
    The newer EN ISO standards are including an Annex Z that identifies specific Essential Requirements sections for which the harmonized standard can be used for compliance.  For instance EN ISO 14630 can be used for compliance to Section 7.1 but not Section 7.2.  Some of the older harmonized standards do not have this annex nor do the ISO standards purchased without the EN designation.  Does anyone have a source for exactly which harmonized standards can be used to show conformity?  The Essential Requirements play a major role in conformance to the MDD.  It seems like there should be a list somewhere to help us stay compliant. 

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    John Minier RAC
    Stryker - Small Bone Innovations
    Morrisville PA
    United States
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  • 2.  RE: Standards to satisfy Essential Requirements Sections

    Posted 31-Oct-2014 12:17
    John,

    You may get the list at http://www.regulatorydoctor.com/?attachment_id=15072


    Original Message


  • 3.  RE: Standards to satisfy Essential Requirements Sections

    Posted 31-Oct-2014 14:22

    I think you are looking for the list of harmonized standards. The EU standards organization, CEN, often adopts an ISO standard. When they do, CEN adds the appropriate annexes to provide a cross reference between the Essential Requirements (MDD, IVDD, and AIMD) and the clauses in the standard.

     

    The harmonized standards have a special place in the legal framework of the EU called a presumption of conformity. It is always to your advantage to use a harmonized standard. Typically, your Notified Body will expect it.

     

    To get the list of Harmonized Standards go to http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

     

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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: Standards to satisfy Essential Requirements Sections

    Posted 31-Oct-2014 14:46
    It can/will be very practical/helpful if one also uses other guidances to reasonably/accurately narrow it down to the heart of interpreting the relevant standards within the meaning and scope of applicable Directive(s) in EU, in particular risk management and clinical evaluation.  

    For example, EN ISO 14971:2012 v. MDD/IVDD/AIMDD as shown at http://www.regulatorydoctor.com/interpretation-and-application-of-annexes-z-in-en-iso-14971-2012/


    Original Message