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  • 1.  EU MDR - CMR Substances

    This message was posted by a user wishing to remain anonymous
    Posted 20-Feb-2023 08:22
    This message was posted by a user wishing to remain anonymous

    Hi All, 

    I have a question on CMR substances under MDR. The MDR states that the IFU of devices consisting of CMR substances must contain "precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the patient or user;". My question is 1. Is the addition of the cobalt symbol alone sufficient to meet this requirement? 2. Do you consider this a significant labelling change under NBOG 2014-3 requiring Notified Body approval? I think it could be considered not significant on the basis of the below statement from NBOG. Do you agree? I would be very grateful for any input. Thanks.

    "Minor changes to clarify the existing wording of the warnings and precautions for a device may
    not trigger the need for approval. However, in the case where these changes add or remove a
    contraindication, or remove a warning or precaution, an approval by the Notified Body is required."



  • 2.  RE: EU MDR - CMR Substances

    Posted 24-Feb-2023 11:12

    Hi Anon,

    I do not have any recent experience how a notified body would review this but from my point of view:

    1. The MDR is not completely consistent on the issue of labeling for CMR substances. Annex I section 10.4.5 states that the presence of CMR substances above the 0.1% limit must be indicated and that for vulnerable patients/users "information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use." This seems more limited than the general requirement you cite (23.4 (s), last indent). My current interpretation would be that section 23.4 just details that the precautions that might be necessary under 10.4.5 must be included in the IFU. However, I think in both cases it is clear that information on the presence of a CMR substance and necessary precautions are two different things. Just adding the symbol therefore to me seems not sufficient without a risk-based, documented rationale why no additional warnings or instructions for precautions are required.
    2. This is difficult to say without additional information. Is the device in question already MDR compliant or is this a legacy device? NBOG 2014-3 would only be applicable for the latter and for the former there currently is - as far as I know - no MDCG guidance. In addition the decision would depend on the conformity assessment procedure chosen for the specific device. In any case it probably makes sense to form a decision and rationale and discuss it with your notified body in advance, if possible.


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    Christoph Kiesselbach
    Reutlingen
    Germany
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