MedTech Europe has published a paper which aims at clarifying what symbols developed for the Medical Devices Regulation compliance may be potentially used by the IVD sector (see below) and which ones are not to be used as the IVD Regulation does not require certain information to be added to the label (i.e., containing biological material of animal origin or contains a medicinal product)
Translation
Why should you add this symbol to your product label?
This symbol has been developed to indicate that the original medical device information has undergone a translation which supplements or replaces the original information. This symbol should only be used by an entity that is not the manufacturer.
Repackaging
Why should you add this symbol to your product label?
This symbol has been developed to meet a regulatory requirement to indicate on the label of the device that it is a medical device. Note that this symbol is only available in the ISO 15223-1: 2021, not in the OBP (Online Browsing Platform (add link).
Importer
Why should you add this symbol to your product label?
To meet a regulatory requirement, medical devices must indicate the identity and address of the Importer. This symbol is useful to indicate the entity importing the medical device into the locale.
Distributor
Why should you add this symbol to your product label?
To meet a regulatory requirement, medical devices must indicate the identity and address of the Distributor. This symbol is useful to indicate the entity distributing the medical device into the locale.
The Importer and Distributor symbols have been created to indicate those entities directly on the device and can be used in both the MD and IVD sectors. It is also possible to use them together with the “Translation” and “Repackaging” symbols.
For more information on the use of these symbols, please consult ISO 15223-1: 2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements. Note that useful examples are included
