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  • 1.  ISO/AWI TR 20416

    Posted 13-Feb-2018 13:40
    Hello everyone,

    Does someone have information concerning ISO/AWI TR 20416 on post-market surveillance for medical devices?

    Do you know if it will be taking into account requirements of the European MDR 2017/745?

    Thank you very much for your support!

    Best regards,
    Leo


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    Leonardo Ruggiero

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  • 2.  RE: ISO/AWI TR 20416

    Posted 14-Feb-2018 04:29
    I would be interested to know information about the status of this standard as well ... someone on TC210 that can provide some info?

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: ISO/AWI TR 20416

    Posted 14-Feb-2018 05:14
    Edited by Marcelo Antunes 14-Feb-2018 05:15
    It's being drafted at the moment, with several web-meetings to polish the text.

    Regarding taking into account the requirements of the MDR, it is taking them into account...sort of. Although the document is not focused in any regulation, my original comments on the process:

    (to use a step-by-step process such as this:

    1.1. Identify the need for information.

    1.2. Identify the general goal of the information use

    1.3. Create a serie of fundamental questions to what information wants to answer

    1.4. Identify how the information will be used in practice

    1,5. Identify sources

    1.6. Identify proactive and reactive methods by which information will be sought

    1.7. Develop a search for information based on the chosen method

    2. Apply the method

    3. Put in a table and analyze data

    4. Create a report

    5. Decide which appropriate action is required from the results. 

    6. Report the results and plans for all involved)

    I created to fulfill the new MDR requirements for PMS some client (including the examples on fundamental and primary questions and response variables, the search methods derived from social sciences literature and the example of search protocol).

    It will also have some comments on trend analysis, which is a new requirement from the MDR and that still has only a few sources such as the old GHTF documents.

    But it's still a working draft, a draft available to NCs will be circulated in some time.



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    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
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    Original Message


  • 4.  RE: ISO/AWI TR 20416

    Posted 14-Feb-2018 10:09
    I am an active member of WG6 for this TR. We are working though comments to have a draft document for circulation some time this summer. The draft is working to take into account the EU MDR requirements, however I very much caution that the TR is focused on the definition of post-market surveillance from ISO 13485:2016

    3.14
    post-market surveillance
    systematic process to collect and analyse experience gained from medical devices that have been placed on the market

    This means that it is limited to the collection and analysis of the data. There are other quality management systems that focus on the actions to be taken with this data. In addition, I remind you that this is NOT a standard, but is guidance that is provided in the form of a technical report. It is important that everyone realize that this will not outline the fulfillment of your organizations obligations in accordance with the applicable regulatory requirements.

    Please feel free to send a message if you have any questions (when the draft is circulated for public review, we can post a notification).

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    Regards,
    Mark Swanson, MBA, ASQ CBA, CMQ/OE, CQE
    Becker MN
    United States
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    Original Message


  • 5.  RE: ISO/AWI TR 20416

    Posted 14-Feb-2018 11:21

    Mark,

     

    I'm very interested in the "collection and analysis of the data". In general I'm hoping for a set of statistically based analysis methods such as disproportionality analysis. I'm also hoping for some Bayesian analysis relative to risk management. (For example, the frequency of occurrence estimate for the residual risk in ISO 14971:2007 is the prior distribution, and complaint data can update the analysis to generate a posterior distribution.)

     

    One area of specific interest for me comes from the EU-MDR Article 88 Trend Reporting which says that manufacturers report, "any statistically significant increase in the frequency or severity of incidents that are not serious incidents". I hope the techniques would include methods to determine these statistically significant increases.

     

    Is the direction of the document going toward these kinds of analytical techniques and methods?



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 6.  RE: ISO/AWI TR 20416

    Posted 14-Feb-2018 11:29
    There are mentions of the need to statistical methods and analysis several times, and the document has a sections called "

    10.3 Methods for data analysis, which mention trend analysis, Pareto and Weibull analysis, but in a general way only, without going into depth.



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    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
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    Original Message


  • 7.  RE: ISO/AWI TR 20416

    Posted 16-Feb-2018 08:04
    I would add that a reference to ISO TR 10017 (Guidance on Statistical Techniques for ISO 9001) and GHTF/SG2/N54 (look at section 5 of this document--5 Statistical Trending Example and Significant Increase)

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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    Original Message


  • 8.  RE: ISO/AWI TR 20416

    Posted 15-Feb-2018 02:39
    Dear All,

    Thanks a lot for your answers!

    @Mark Swanson thanks a lot for the clarification. When do you think the draft will be starting circulating?

    From your considerations, I deduct that the TR is not going to cover the "pro-active approach" meaning clinical data collection, isn't it?

    What is the chance that it will evolve in a standard? 

    Thanks a lot for sharing!

    Best regards,

    ​​

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    LeonardoRuggiero

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    Original Message


  • 9.  RE: ISO/AWI TR 20416

    Posted 15-Feb-2018 03:00
    It will include clinical data collection (the examples on primary questions I mentioned before was based on clinical data for breast implants, as the solution I was providing included the new PMCF requirement for an ongoing process). I would just take care with saying that this is "proactive", because there's some interpretation of what proactive is.

    An internal ballot is being expected in March/April, but may be postponed. A committee ballot will probably be circulated after the November WG 6 meeting.

    Regarding evolving into a standard... my impression is that is that this will take a long time, because we still have a lack of consensus on PMS.


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    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
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    Original Message


  • 10.  RE: ISO/AWI TR 20416

    Posted 16-Feb-2018 07:55
    I agree with Marcelo on this. It is very unlikely to evolve into a standard for quite some time as the regulators have little agreement on the regulatory requirements for PMS.

    Clinical evaluation data, clinical studies, post-market clinical follow up study and published literature are all listed as sources of post-market surveillance data. 

    As far as the proactive piece, as part of ISO 13485:2016, in both the general section and the section on feedback, the wording used was intentionally proactive (bolding mine) to follow these regulatory requirements:

    8.1 General
    The organization shall plan and implement the monitoring, measurement, analysis and improvement processes
    needed to:

    8.2.1 Feedback
    As one of the measurements of the effectiveness of the quality management system, the organization shall gather
    and monitor information relating to whether the organization has met customer requirements.

    The need to be proactive in gathering (go out and get) and monitoring (keeping a watch out for) would seem apparent to me in a conforming quality management system.

    I hope this helps!

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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    Original Message


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