Joint industry paper calling for digital label for importer and authorised representative information

Posted on 06.11.2025

Recently, mandatory requirements for additional product information for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) have exponentially increased. Under the current legislative system in the EU, both essential information (information needed for a safe use of the device) as well as additional (non-essential) information must be included on the product’s printed label.

MedTech Europe, the Association of the European Self-Care Industry (AESGP), the European Trade Association representing the medical imaging, health ICT and electromedical industries (COCIR) and the European Manufacturers of contact lenses and lens care (EUROMCONTACT) view this additional information as non-essential to the safe and effective use of the device; as it is unrelated to identification of the device, warnings and precautions, handling & use information (storage, sterility etc.).

Therefore, we call on the European Commission to allow via the upcoming targeted revision of the EU rules for medical technologies, as a first step, that the importer and authorised representative information may be provided via a digital label. We believe that eventually all information which is not essential for the (safe) use of the device should be provided in digital format – pending the outcomes of the dedicated Innovative Health Initiative (IHI) Call 10 Digital label project.

Please consult the full paper to learn more.