In November 2025, MedTech, AESGP, COCIR and EUROMCONTACT released a joint position paper on digital label for Authorised Representative and Importer details. The European associations are calling on the European Commission to allow that the importer and authorised representative information may be provided via a digital label.
Associations ask for non-essential information to go on digital labelling
Under the current framework, the printed device’s labels must include both essential and additional information. According to the associations, information that is not essential for the safe use and for the device identification should not be mandatory elements to affix on the printed labels. Therefore, MedTech, AESGP, COCIR and EUROMCONTACT call on the European Commission to address this aspect in the upcoming revision of the MDR and IVDR. As first step, the associations ask that the importer information and authorised representative information may be provided via a digital label. Eventually, all non-essential information should be provided on the digital labels.
Among the reasons behind this suggestion, the position paper includes:
- Authorised representative on digital labels: manufacturers should have the flexibility to implement changes of EAR details or EAR symbols without raising cost, re-labelling, waste, and similar.
- Importer details on digital labels: there would be no misplacement or loss of physical accompanying documentation before the product reaches the end user. Additionally, it would eliminate the need to update and reprint the whole of the physical label merely to change the importer information.
Do you have questions on MDR and IVDR labelling requirements? Contact us here or at mdlaw@obelis.net.
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