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ISO 14971:2019 and EN ISO 14971:2019 standards

  • 1.  ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 22-Jan-2020 09:25
    ​​Good day to all!

    Now that both 14971:2019 standards (ISO and EN ISO) are available, is there a timeframe such that using the former standards would be incorrect? 

    Or put another way, is there a transition time for implementing the new standard(s) and will you incur a nonconformity if you continue to use to older versions at this point?

    Thanks!

    Margaret Krueger

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    Margaret Krueger
    Saint Paul MN
    United States
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  • 2.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 02:53
    HI Margaret,

    As soon as the standard becomes harmonized, it becomes the requirement. So as such there is no transition time. That being said, it is expected by notified bodies, in my experience, that your QMS would have a procedure which outlines your approach to identifying updated standards and performing a gap analysis. I think if you were to be audited today for example, the fact you have identified the change in standard and that you have a plan for performing the gap analysis, would be sufficient.

    Hope that helps

    Lee

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    Lee Westwood
    Fremantle
    Australia
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    Original Message


  • 3.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 04:24
    Edited by Arthur Brandwood 23-Jan-2020 04:25
    Lee,

    There's almost always always a transition time, where old and new versions overlap and both are recognised.  You can see that in the listing on the Nando webpage at https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en.  Note that the superseded standard often has a cessation date around a year after the recognition of the new standard. 

    However that's often moot given the current stalled process, see my other post.

    You are absolutely right about the importance of monitoring for updates and performance of gap analysis as changes happen.  Auditors always expect that.

    Arthur

    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    ------------------------------

    Original Message


  • 4.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 10:05

    Hi Arthur,

     

    Thank you very much for both your answers!  With that said, I am going to update our documents to align with the newest 14971:2019 standards (ISO and EN ISO).

     

    Thanks again!

     

    Margaret

     




    Original Message


  • 5.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 09:34

    Thank you Lee!  I will definitely check on if our QMS does have a procedure which outlines the approach to identifying updated standards and performing a gap analysis.

     

    Your answer has been very helpful!

     

    Thank you again!

     

    Margaret

     




    Original Message


  • 6.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 04:21
    Hi Margaret,

    The 2019 version (both ISO and EN ISO have been published.  However, as far as I am aware, the EN version has not yet been harmonised.

    This is not surprising as the harmonisation process  for medical devices standards stalled more than 2 years ago.  Since then no new standards have been harmonised against MDD, which means that a number of important harmonised EN standards are now out of date compared to ISO.

    The situation is worst for MDR, where the mandate for harmonisation is hopelessly behind the transition schedule, meaning MDR will come into effect with no harmonised standards, and the arrangements are flawed so that the harmonisation process is in danger of starting off with out of date standards.

    So what to do?  Check with your Notified Body what approach they are taking.  Some are insisting on use of the harmonised standard, as that's what's official, even if its out of date.  Others are invoking the idea that the MDD, and especially the MDR, contain the concept of State of the Art, and that is represented by the latest ISO version of a particular standard, so you should go with that and ignore the out of date harmonisation reference.  An example of this is that several Notified Bodies are invoking the ISO 10993-1:2018 for biocompatibility, even thought the harmonised version is the older 2012 edition.

    It's all very confusing and fraught with traps around interpretation and legal status.

    For a more detailed discussion see  https://brandwoodckc.com/are-harmonised-standards-facing-irrelevance/

    Arthur

    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    ------------------------------

    Original Message


  • 7.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 08:29

    Margaret,

    in the US FDA will accept the 2007 edition Of ISO 14971 until December 25, 2002. They publish this information for standards, including what parts of a standard they accept. In this case the entire standard is accepted. 


    in the EU there remains confusion on standards and CEN expects to publish an Amendment when they receive a Harmonization Request from the EC. When that is published in the Official Journal you will find that information. Right now you can look on the CEN website for expiration information. 


    iSO shows the 2007 edition as Withdrawn and replaced by 2019 edition. 



    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


  • 8.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 10:12

    Thank you Edwin!  That information was very helpful!

     

    I will definitely look at the CEN website.

     

    Thanks again!

     

    Margaret

     




    Original Message


  • 9.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jan-2020 10:40
    This message was posted by a user wishing to remain anonymous

    Dec 25th, 2022?
    Original Message


  • 10.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 13:02
    December 25, 2022 looks accurate. 

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=40369

    ------------------------------
    Alyssa Roelli
    Regulatory Projects Manager
    Milwaukee WI
    United States
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    Original Message


  • 11.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 13:46

    Thank you Alyssa!  Your reply is very helpful!

     

    Thanks again!

     

    Margaret Krueger

     




    Original Message


  • 12.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 14:29
    I was mystified as well by FDA's choice of dates, but that is what was posted on the Recognized Standards database. Dec 25, 2022!

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 13.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 23-Jan-2020 20:00
      |   view attached
    I've attached a document I prepared for my clients to help them understand the current situation. It is my understanding the the international, US, EU, and Canada situation.

    I welcome comments.

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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Attachment(s)

    docx
    14971 Status.docx   18 KB 1 version
    Original Message


  • 14.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 24-Jan-2020 09:59
    The European Forward in EN ISO 14971:2019 says this standard will be given national status by June 2020.  All conflicting standards shall be withdrawn at the latest by June 2020.  I interpret that to mean this standard is effective June 2020.​

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    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
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    Original Message


  • 15.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 24-Jan-2020 11:10

    Thank you Al!

     




    Original Message


  • 16.  RE: ISO 14971:2019 and EN ISO 14971:2019 standards

    Posted 24-Jan-2020 18:42

    To see the applicable dates, go to

    https://standards.cen.eu/dyn/www/f?p=CENWEB:105::RESET::::

    In Standard Reference enter 14971

    Select Search, it will return two standards

    Click on EN ISO 14971:2019

    The date you cite is the Date of Publication and the Date of Withdrawal. See footnotes 4 & 5 for an explanation

    There is no Date of Implementation, meaning users of the standard must implement it.

    If the standard were to become harmonized there would be a Date of Cessation of Presumption of Conformity of Superseded Standard meaning, "Generally the date of cessation of presumption of conformity will be the date of withdrawal, set by the European standardization organization, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise".

    I think it is reasonable to believe that, in this case, manufacturers should implement EN ISO 14971:2019 by June 30, 2020.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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