Digital label for authorised representative and importer

Mandatory requirements for additional product information  for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) have exponentially increased recently. Under the current legislative system in the EU, both essential information (information needed for a safe use of the device) as well as additional information must be included on the product’s printed label. MedTech Europe, AESGP, COCIR and 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 and the co-legislators to allow via the upcoming MDR/IVDR legislative revision, 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 IHI Call 10 Digital label project.

Please consult the full paper to learn more.