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  • 1.  When you perform a gap analysis and find you meet the updated standard, do you update your DOC and IFU with the latest?

    This message was posted by a user wishing to remain anonymous
    Posted 25-Oct-2022 11:11
    This message was posted by a user wishing to remain anonymous

    If you have a test report stating that you meet ISO 14971:2007, but you perform an internal gap analysis and update your documentation to meet ISO 14971:2019, can you say that you meet ISO 14971:2019 in your documentation, e.g., in your IFU and in your EU DoCs? Or are you required to have an official test report stating you meet the updated standard?


  • 2.  RE: When you perform a gap analysis and find you meet the updated standard, do you update your DOC and IFU with the latest?

    Posted 25-Oct-2022 11:35
    We do. The evidence is presented in a gap memo. 

    Example: ISO XYZ:2015 is being replaced by ISO XYZ:2022. The changes in 2022 version are limited to sterile devices. Your device is not sterile. Your memo may claim compliance with XYZ:2022 and explain why it is compliant in the memo.

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 3.  RE: When you perform a gap analysis and find you meet the updated standard, do you update your DOC and IFU with the latest?

    Posted 25-Oct-2022 13:01

    You probably have a test report to IEC standard using ISO 14971:2007 as opposed to a test report for ISO 14971:2007 only.

    Since you ask about the EU, I'm going to switch to their standards.

    There is a new version of an EN standard, assume CENELEC, that you implement and then use a test house to prepare the report. To support the new version of the EN CENELEC standard, then you should have implemented EN ISO 14971:2019/A11:2021. The report from the test should cite this EN standard.

    When you updated to EN ISO 14971:2019/A11:2021 you need to update your MDR Annex I documentation and your MDR Annex II documentation.

    EN ISO 14971:2019/A11:2021 is harmonized to the EU-MDR, so you need to update the list of harmonized standards on your DoC.

    I don't think the IFU requires a list of standards such as the risk management standard you implemented. If there is no requirement, I would take it out of the IFU to avoid the maintenance issue.



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


  • 4.  RE: When you perform a gap analysis and find you meet the updated standard, do you update your DOC and IFU with the latest?

    Posted 26-Oct-2022 01:58

    Please pardon my outspokenness Dan, but I believe that the Annex IV on DoC doesn't require a list of harmonized standards, although some manufacturers still add it.



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    Richard Jansky
    Head of RA / RM / QM
    Beringen
    Switzerland
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    Original Message


  • 5.  RE: When you perform a gap analysis and find you meet the updated standard, do you update your DOC and IFU with the latest?

    Posted 26-Oct-2022 11:16
    You are correct. It says, "References to any CS used and in relation to which conformity is declared". I misremembered it as including but CS and Harmonized Standards.

    Thank you for the correction.

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


  • 6.  RE: When you perform a gap analysis and find you meet the updated standard, do you update your DOC and IFU with the latest?

    Posted 26-Oct-2022 12:23
    In my experience in more than 25 years of being audited by multiple of the most prolific and difficult European Notified Bodies (e.g., TUV, BSi, and others), I've never had one demand an outside test house/lab report showing my or my clients' conformity with EN ISO 14971 as amended (nor with the old EN 1441 that we used to use before EN ISO 14971 was born). Instead, it has always been sufficient to demonstrate conformity via appropriate objective evidence.

    Indeed, the main risk management requirements of the EU MDR [i.e., Articles 10(2), 10(4), 10(9) third paragraph indent (e), Annex I.3, Annex II.5, etc.] don't demand an official report from an outside test house/lab.  Instead, they require, "technical documentation" that "contain information on...the solutions adopted..." [emphasis added], and, "technical documentation" that is "...such as to allow the conformity of the device with the requirements of [the EU MDR] to be assessed. [emphasis added].

    Your in-house objective evidence of conformity could certainly take the form of a "test report", but could also be another type of documented evidence such as itemization in your GSPR checklist, a memo, a separate trace matrix, etc.

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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