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  • 1.  Labelling class I reusable medical device under MDR

    This message was posted by a user wishing to remain anonymous
    Posted 28-Nov-2022 09:03
    This message was posted by a user wishing to remain anonymous

    Hi everyone,
    We have class I reusable medical device to be marketed under MDR. It is meant to be reprocessed. It is quite small about half of the size of a computer mouse. Should it also be labelled (in this case laser engraved) like the other medical devices under Annex I, 23.2. To include short intended purpose, address of the manufacturer, MD symbol, UDI, CE, SN, LOT.
    Or to avoid too many info on the device itself (limited space/risk of corrossion), we can consider this part of the MDR
    23.1 (b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.

    What is the minimum labelling info on a reusable class I medical device?

    Thanks a lot and regards,
    Chona


  • 2.  RE: Labelling class I reusable medical device under MDR

    Posted 29-Nov-2022 13:04
    Edited by Kevin Randall 29-Nov-2022 13:14
    Remember that Annex I, Section 23.2 (Information on the label) requires up to nineteen different informational attributes, whereas your cited Section 23.2 list only includes seven.  Therefore, so that you are fully attending to the minimum information required to, as a general rule, be on the label, be sure that your plan and implementation for the device label address all nineteen of Section 23.2's various label information attributes.

    As a general rule, the EU MDR doesn't appear to exclude reusable devices from Section 23.1(b)'s practicability/appropriateness concessions.

    However, be sure you also carefully consider any adjustments needed with regard to the additional label requirements for the UDI carrier in Annex VI, Part C, Section 4 as applicable to your particular device.

    Be sure to also consider Section 23.1(a)'s additional boundaries as applicable to the nature of your particular subject device/scenario.

    Finally, for whichever of the Section 23.2 attributes you choose not to have on the device itself, then be sure your approach is supported by corresponding risk analysis.  In other words, if the device itself doesn't contain all nineteen (as applicable) of Section 23.2's required attributes (thus meaning that such attributes must instead appear on packaging), then such approach must yield a device that remains within the risk acceptance criteria prescribed in the device's Risk Management Plan.

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
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