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  • 1.  MDR and ISO 11607 harmonisation

    Posted 09-Aug-2021 10:01
    Hi all
    Does anyone have the latest status on the harmonisation of ISO 11607 with the MDR?  I saw that the amendments for parts 1 and 2 went to vote on 23 July this year.  When does the vote close and what is the latest on the publishing of the technical document to go with both standards?

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    Mary Corcoran
    Regulatory Affairs Manager EMEA
    Sligo
    Ireland
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  • 2.  RE: MDR and ISO 11607 harmonisation

    Posted 10-Aug-2021 11:39
    Hello Mary,

    You have probably seen there has been one list of 5 standards which were harmonised under the EU MDR.  Others are supposedly coming, but I would suspect it will still be a while.  There are a lot of standards to get through.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: MDR and ISO 11607 harmonisation

    Posted 10-Aug-2021 11:43
    Hi Richard
    Yes, I am aware of these, but as we make a sterile barrier system product, I guess we have major interest in ISO 11607 harmonisation. 

    Best regards

    Mary  Corcoran
    Regulatory Affairs Manager
    C/o Amcor Flexibles Sligo

    Finisklin Business Park 

    Sligo 

    F91 N674 



    Tel: +353 85 870 1036
    Website:  www.amcor.com

     
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    Original Message


  • 4.  RE: MDR and ISO 11607 harmonisation

    Posted 01-Sep-2021 10:16
    The plan is to 'periodically' update the standards cited in the OJEU. The last I heard the EU Commission was saying this would be every 6 months or so. :(

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    Lena Cordie-Bancroft
    Victoria MN
    United States
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    Original Message


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