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  • 1.  MDR Definition

    Posted 25-Jan-2022 12:27
    Edited by Ed Panek 25-Jan-2022 12:31
    In the phrase "Previous generations of the device" what is meant by "generations?"   When does one generation end and a new one begin? Are they able to exist at the same time?

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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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  • 2.  RE: MDR Definition

    Posted 25-Jan-2022 20:50
    That one is nebulous.

    You know it when you see it?  I take it to mean something bigger than a version change, though even a version change could count. It could be a new generation when you roll from 3.4 to 4.0. It could be a new generation when you have a whole new model name for a new design of something that performs mainly the same function as some older device. Or when your marketing team describes it as the "next gen" whatever-it-is.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: MDR Definition

    Posted 25-Jan-2022 21:07
    I've seen BSI give the following guidance:

    All submissions should be accompanied by a market history to enable an understanding of the context of device development.

    • If the device is new and has never been marketed by the manufacturer anywhere in the world, please state this explicitly.

    • For existing devices:
    - Ensure that a market history is provided indicating the nature and timing of any changes and that any associated documents (i.e. risk analyses, labelling, clinical evaluation reports, verification / validation data, etc.) account for these changes.
    - Provide evidence (e.g., BSI Reference numbers of previous reviews) to demonstrate that BSI has been notified of all significant changes (if applicable).
    - For initial applications under MDR, please confirm whether the device has been previously marketed under MDD and whether any changes have been made in comparison to the MDD-certified device
    - Market history should include EU and approvals in other geographies.

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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


  • 4.  RE: MDR Definition

    Posted 26-Jan-2022 04:15
    Hi Ed,

    I would support the list Kevin provided as I have seen this as well - in particular if this is a brand new device clearly and explicitly make this statement.  Also agree with Anne it can be quite nebulous because some companies have clear designated versions of a device.  Though as an example when a company has Model 100 they have been selling for 10 years and then come out with Model 200 (discontinuing Model 100 ... or not) then is Model 100 a previous generation of Model 200?  This has to be clearly described and stated by the company.  Because maybe Model 200 is a completely brand new device and has nothing to do with Model 100.  Or maybe the company has decided to re-brand making Model 200, but "under the hood" it is still much Model 100, so it would be a previous generation/version.  Short answer is the company needs to define where one generation/model/version/part number/sales number begins and another ends and yes different generations can exist on the market at the same time.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: MDR Definition

    Posted 26-Jan-2022 08:37
    Thanks All!

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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


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