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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."