Regulatory Open Forum

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  • 1.  Novel Features

    Posted 20 days ago

    Hi all,

    MDR Annex II, Section 1-1.1(g) lists "novel features" as an element to be discussed in technical documentation. However, "novel features" is not defined in the MDR, and I am not finding any official definition for this term elsewhere. Is there a consensus as to what "novel features" refers to?

    Thanks!



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    Thomas Saladin
    Regulatory Affairs Specialist
    Laborie Medical Technologies Canada ULC
    Minnetonka MN
    United States
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  • 2.  RE: Novel Features

    Posted 20 days ago

    Start with Annex II, 1.2 which is about previous generations and similar devices. (The section heading has a typo.)

    The expectation is that you will provide an overview of these devices. Each of them will have features which will be in the overview.

    If your current device has a feature that other devices (or perhaps vey few) have then it is a novel feature. Think of this from the point of marketing. A common approach is a table that provides a side-by-side comparison of your device compared to earlier versions or to the competitors or both. When your device has a feature that others don't have, it is a novel feature.

    In terms of Kano analysis it is a delighter. Your customers will be delighted to have this novel feature.



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


  • 3.  RE: Novel Features

    Posted 19 days ago

    A good official reference would be the "Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure" which includes the novelty criteria for CECP screening.  EUR-Lex - 52020XC0807(01) - EN - EUR-Lex (europa.eu)

    NBs/Other colleagues may also refer to the ANSM card, such as G-MED guidance published in 2020 (GMED_Guide-MD_Clinical_Evaluation-MDR.pdf (lne-gmed.com)) & TeamNB positioning paper Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V1-20221005.pdf adopted in Oct. 2022. But please also note that, BSI webinar CECP said "Do Not Use the ANSM Card – Requested by Secretariat" in their slides of Nov. 2022. So be careful with that for the context of CECP.



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    Minghua Chen
    BD Manager, APAC
    Qserve Group (China)
    Nanjing
    China
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    Original Message


  • 4.  RE: Novel Features

    Posted 19 days ago

    Dear Thomas,

    you may find information within the Commission guidance: 
    "Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure (Text with EEA relevance) (2020/C 259/02)"

    This document can be found here:

    EUR-Lex - 52020XC0807(01) - EN - EUR-Lex

    Europa remove preview
    EUR-Lex - 52020XC0807(01) - EN - EUR-Lex
    Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure (Text with EEA relevance) (2020/C 259/02) Table of contents 1.
    View this on Europa >

    Here is an excerpt:

    "2.   Criterion 1: novelty and clinical or health impact

    This section provides guidance on how to assess the novelty of a device or its associated clinical procedure and how to estimate the possible major clinical and health impact of that novelty.

    The novelty criterion relates directly to the device or the related clinical procedure under assessment and can therefore be evaluated based on the available documents, i.e. the CEAR prepared by the notified body as well as the accompanying documents, in particular the manufacturer's clinical evaluation report (CER).

    Novelty typically means that there is a lack of experience in regard to the safety and performance of the device or specific features of the device or related clinical procedure, and there are no similar devices or insufficient experience with similar devices to enable straightforward appraisal of its future real-world safety and performance. However, in case of innovation based on modifications of previous variants of the device, relevant information coming from the post-market surveillance may be available and needs to be considered. To this end, the expert panel needs to estimate the clinical impact or health impact in conjunction with the novelty. Novelty alone is insufficient to trigger a scientific opinion. Rather, the panel needs to consider any possible major clinical and/or health impacts resulting from that novelty.

    Conversely, potential clinical or health impacts that are not linked to a novel device (or novel features of a device) or a novel clinical procedure will not trigger a scientific opinion.

    2.1.   Assessment of novelty dimensions

    ..."



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    Ludger Moeller
    President, MDSS GmbH
    l.moeller@mdssar.com
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    Original Message


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