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Symbols for compliance with the IVDR/MDR

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MedTech Europe provides information on the use of certain new symbols to support compliance to the Medical Devices Regulation and In vitro Diagnostic Medical Devices Regulation.

In Europe, the necessity to translate in a large number of languages the information provided on the labels, creates the need for manufacturers to use symbols. The use of appropriate symbols on the label of medical devices and IVDs is also required by the European Medical Devices and IVD Regulations. Where appropriate, symbols therefore are used on the medical device label as an alternative to written language. Symbols are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device.

The Medical Devices and IVD Regulations set out new label requirements.. These requirements differ substantially from one Regulation to the other. To understand which symbols are specific to compliance with the Medical Devices Regulation and which symbols should or should not be used for compliance with the IVD Regulation, please see the MedTech Europe paper.

Disclaimer:

MedTech Europe has created this website to help users familiarise themselves with MDR/IVR-related symbols. MedTech Europe did not create these symbols. They are included in ISO15223-1:2021. We believe the representation of the symbols is accurate to the best of our knowledge at the time of publishing of this website (ADD DATE). Therefore, MedTech Europe cannot be held liable for any use of the symbols here showcased nor for any discrepancy between the present guidance and any other representation of ISO15223-1:2021 by third parties. As such MedTech Europe is not responsible for any damage or loss incurred by any of its members or any third party acting based on the contents of this website.

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