A coalition of leading European associations: MedTech Europe, AESGP, COCIR, and Euromcontact, has published a joint position paper urging the European Commission to allow Authorised Representative (AR) and Importer information to be provided via digital labels in the next revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Source
Under current rules, both AR and importer details must appear on the physical device label or accompanying documentation. This often results in crowded labels, frequent reprints when partners change, and increased packaging waste. The proposed digital format would make such non-essential information available through machine-readable links such as QR codes or data matrices, while maintaining all safety-critical information on the physical label.
According to the paper, digital labelling would:
- Align MDR/IVDR with the EU Green Deal and other horizontal regulations (e.g. Ecodesign Regulation, Digital Product Passport);
- Reduce environmental impact by eliminating redundant packaging;
- Simplify relabelling when importer or AR changes occur, avoiding delays in device availability;
- Support digital traceability across the medical device lifecycle.
This initiative is also consistent with the IHI Digital Label Project, which is exploring harmonised approaches for providing non-essential regulatory information in digital form.
From MedQAIR’s perspective, this is a positive and pragmatic step for both manufacturers and Economic Operators. It reduces administrative burden, prevents mislabeling risks, and supports faster market updates without compromising compliance.
Platforms such as MDIS are already positioned to support this shift, providing a structured, audit-ready environment for document traceability, Basic UDI tracking, and lifecycle updates between manufacturers and their partners.
The European Commission is expected to consider this recommendation as part of the upcoming MDR/IVDR legislative revision.
If implemented, digital labelling could mark a major step toward paper-light compliance, real-time data traceability, and simplified lifecycle management across the EU medical device ecosystem.
Manufacturers preparing for these changes can strengthen their digital readiness today. MedQAIR supports medical device companies in aligning documentation, labelling, and traceability workflows with evolving EU requirements. To discuss how your organisation can adapt its compliance processes, contact our team.
