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  • 1.  EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 19-Nov-2019 03:58
    Hi all,

    I am new to RAPS and I hope that you might be able to help me. I am reponsible for risk management of Class III (implantable) devices acc. MDD/MDR.
    We want to file a last change notification acc. MDD in january 2020. I am not sure how to address the state of the art regarding risk management for the device. As I have to prepare the risk management file now, state of the art would be EN ISO 14971:2012 (as I understand it - please correct me if I'm wrong). When we will send the technical documentation in January 2020, supposedly ISO 1491:2019 will be the most current version of the standard. As far as I know the EN ISO version will be published in december 2019 as well.

    Up to today, we use the annexes of EN ISO 14971:2012 intensively as base for our risk analysis (e.g. Annex C). These annexes were deleted in ISO/DIS 14971:2018 and moved to ISO/TR 24971:20XX which is not pubished yet. No draft of ISO/TR 24971:20XX is available yet, either.

    I am not sure, how to proceed:
    1. Is it wise to finalize the risk management file in early december, that it dates prior release of ISO 14971:2019 and hope for the best?
    2. Or should I prepare a gap analysis and a time table when I will complete the transition? This might bring a timing problem upon me, as we need the CE-Certificate prior 25. May 2020, to be still able to file under MDD.
    3. Was anybody of you able to glimpse ISO/TR 24971:20XX? Are there major changes which I need to address in my risk management file?

    Thank you for your help,

    Regards

    Britta

    ------------------------------
    Britta Cyron
    Bochum
    Germany
    ------------------------------


  • 2.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 19-Nov-2019 11:14
    There are some issues to consider.

    It appears you have ISO/DIS 14971:2018. As I understand, ISO 14971:2019 and EN ISO 14971:2019 will be the same as the draft. If you implement the draft, you will not be out of compliance with ISO 14971:2007. The changes are not contradictory. For example, you would add another element to your risk management plan for the acceptability of the overall residual. However, the acceptability criteria should already have been in your plan.

    You will need to make some decisions about the content deviations in EN ISO 14971:2012. Some of them point out real differences between ISO 14971:2007 and the directives, while others have been misunderstood. For example, there is no prohibition about using information for safety to reduce residual risk; the content deviation is about disclosing residual risk.

    When CEN issues EN ISO 14971:2019, then EN ISO 14971:2012 will become obsolete. However, ISO 14971:2019 does not agree completely with the MDD or the MDR, so you will need to determine the differences that apply to your product and follow the directive or regulation, not the standard.

    I infer from your question that you are revising the MDD technical documentation in preparation for the MDR Article 120 transition. My answers would be different if you were preparing the technical documentation for a full MDR Annex IX application.

    Is it wise to finalize the risk management file in early December, that it dates prior release of ISO 14971:2019 and hope for the best?

    The bulk of the risk management file will not change because of the new standard. Implement the DIS version and you will be fine. However, you will need a plan for those areas where the DIS differs from the MDD.

    Or should I prepare a gap analysis and a time table when I will complete the transition? This might bring a timing problem upon me, as we need the CE-Certificate prior 25 May 2020, to be still able to file under MDD.

    Because the changes to the new version are not great, I would do a gap analysis between the new version and the MDD and close the gaps in favor of the MDD. I don't see a need for a time table.

    I don't understand, "still able to file under MDD". After May 25, 2020, your device must be under either MDR Article 120 or full MDR. Under MDR Article 120, the technical files are the MDD version, not the MDR version.

    Was anybody of you able to glimpse ISO/TR 24971:20XX? Are there major changes which I need to address in my risk management file?
     

    ISO/TR 24971:20XX does not contain any requirements, so it will not make any changes to your technical file. There is a similar situation with EN ISO 14971:2012, Annex C. It is informative, not required. The requirement is in EN ISO 14971:2012, 4.2 to document issues related to safety. "Annex C contains questions such as those relating to use that can serve as a useful guide in identifying medical device characteristics that could have an impact on safety". Annex C is not a requirement, so don't make it one. Use it to help.



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


  • 3.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 20-Nov-2019 02:03
    Hi Dan,
    thank you for your comprehensive answer.
    Regarding your assumptions:
    • Yes, I have the ISO/DIS 14971:2018. As for the acceptance of the overall residual risk, we have already implemented it in our RM quite a while ago. So I didn't recognize it as new requirement. because when I read the ISO/DIS, I had my own templates rather than the EN ISO 14971:2012 in mind to check against
    • We worked out a work around for the information for safety to reduce residual risk, so I won't touch it if I don't have to.
    • Yes, I prepare for the MDR Article 120 transition, not a full MDR Certification. Sorry for not being more clearly, but I am not an English native speaker/writer (as you have probably guessed)
    • Thank you for pointing out the difference between requirements and informative annexes. It tends to slip my mind :-)

    Is there by any chance someone who already prepared a gap analysis between EN ISO 14971:2012 and ISO/DIS 14971:2018 and willing to share?


    Thank you so much!

    Regards,

    Britta

    ------------------------------
    Britta Cyron
    Bochum
    Germany
    ------------------------------

    Original Message


  • 4.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 20-Nov-2019 07:48
      |   view attached

    Britta,

    The role of EN ISO 14971:2012 is the gap analysis between the MDD and ISO 14971:2007. In my opinion, it was not well done and has many errors. I believe you need a gap analysis between ISO 14971:2029 and the MDD. EN ISO 14971:2012 should go away next month. I do have this gap analysis, but perhaps someone does.

    There will be a need for a gap analysis between ISO 14971:2019 and the EU-MDR. I've attached my first pass.

    Dan



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

    docx
    EU-MDR - ISO 14971-2019 Considerations.docx   39 KB 1 version
    Original Message


  • 5.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 20-Nov-2019 08:20
    Dan,
    Thank you so much! This helps a LOT!

    Britta

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    Britta Cyron
    Bochum
    Germany
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    Original Message


  • 6.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 21-Nov-2019 10:24

    As of this morning, EN ISO 14971:2019 is out for vote by CEN and CENELEC to publish the standard without the Z Annexes due to issues with Harmonization process. If all goes according to plan, the standard at ISO/IEC and CEN/CENELEC could be published along with ISO TR 24971:2019 could be published I later third of December. If not, all the documents will appear and be identified as 2020 documents. Because their is an agreement between ISO IEC and CEN CENELEC to publish concurrently they must occur together. 


    it is very important that everyone get both the standard (ISO 14971) and the guidance (ISO TR 24971) (both ISO and EN will be identical) as the documents have been reorganized and most of the informative annexes now appear in ISO TR 24971. This is the information on application of ISO 14971 and has been greatly revised and updated. 


    I did a webinar at Greenlight Guru today on the new documents with the latest information. 



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

    Original Message


  • 7.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 20-Nov-2019 08:43

    ISO 14971:2019 and ISO TR 24971:2019 are expected to be published next month, as are EN ISO 14971:2019 and EN ISO 24971:2019. Until some issues around harmonization are addressed then publication in the Official Journal of the standard will make EN ISO 14971:2012 obsolete. I have a webinar Thursday Nov 21 at Greenlight Guru identifying the content highlights of the new documents compared to the old. There will be the latest on status of EU. 


    Short answer is I agree with Dan, but you will have to satisfy your Notified Body. The opinions of the Notified Bodies on the issues around standards are unknown at this time. So you are on soft ground around this issue and they cannot consult. You are going to be in a difficult spot until you get the results of their audit so you can determine how to proceed. 



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

    Original Message


  • 8.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 21-Nov-2019 10:18
    There is a webinar on the updated ISO 14971 standard today that is free.  It will also be available on their site after today as well if you miss it. 

    https://www.greenlight.guru/webinar/iso-14971-2019-iso-tr-24971-new-changes


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


  • 9.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    This message was posted by a user wishing to remain anonymous
    Posted 22-Nov-2019 09:15
    This message was posted by a user wishing to remain anonymous

    I am excited to see those questions removed from the standard! SO many companies have used those questions and only those questions to build their RMF. The standard and the annex clearly state that "the questions can aid the reader" and "the list is not exhaustive or representative of all devices." These questions were never meant to become a form in the risk management process at medical device manufacturers, but unfortunately that has been the case, with  entities conducting 60601 testing requiring all of these questions be part of the RMR. 

    To answer part of your question, I would use the removal of these questions from the standard as an opportunity to create a more robust and device/company specific RM process. 

    With the release of an revision to a standard, notified bodies and other regulatory agencies understand that compliance cannot occur overnight and a transition period is usually stipulated. I would move forward with the current version for the files you want to submit.

    Within your company, if you do not already have a process in place on how to evaluate and address changes to standards to which you comply, I would suggest you put a process in place, then follow that process as part of your QMS.
    Original Message


  • 10.  RE: EN ISO 14971:2012 vs. ISO 14971:2019

    Posted 22-Nov-2019 11:15
    The questions were never a part of the requirements in the standard.  They were a part of the informative annexes, which were guidance on possible ways to implement risk management.  The confusion between the informative annexes and the requirements being in one document led to the moving of most of the informative annexes to the technical report ISO TR 24971:20(19) [hopefully it will be 2019].  Now we can point out more effectively that the information in ISO TR 24971 IS guidance and not requirements.

    Additionally, as been pointed out earlier, the questions are not an exhaustive list, nor do all questions apply to all devices.  They are suggestions on how to approach safety-related characteristics.  

    DO NOT blindly implement ISO 14971 without understanding the process AND the purpose of risk management.  It is NOT a checkbox activity that once documents are in the file you are done.  It is a living activity for the entire lifecycle of the device, including all in the field.  Pay close attention to Clause 10 on Postmarket Information in the 3rd edition.   This addresses regulatory requirements for EU-MDR and FDA Postmarket Surveillance.

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

    Original Message


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