EU MDR Label Location

Question: Other than the product label, where should the EU Medical Device Regulation (MDR) symbol labels be shown?

Answer: Based on official guidance from MedTech Europe, labels must be placed on the medical product’s “instructions for use” document at a minimum. However, an EU MDR notified body may also require the information to be displayed on the product’s packaging and/or the product itself as a condition of the device’s approval.

It is best practice to include these labels in and/or on the device’s packaging information. Also note that the symbols used on medical device labels under EU MDR are still undergoing ISO consideration and may be subject to change.


Article is current as of 2020-01-10.

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