Tuttlingen – Despite all the advantages, the use of electronic instructions for use (eIFU) is still limited to certain product groups. MedicalMountains GmbH and SPECTARIS would like to further promote this topic politically and are therefore conducting a joint survey.
The requirements for the use of electronic instructions for use for medical devices are regulated in the Implementing Regulation (EU) 2021/2226 on the MDR. For "legacy devices" according to Article 120, Paragraph 3, the previous Regulation (EU) No. 207/2012 for the use of eIFU continues to apply. Both regulations limit the use of electronic instructions for use to certain product groups - despite the pressure from national and European associations to expand the scope.
In November 2022, the European umbrella organization MedTech Europe (MTE) published a position paper that calls for the use of an eIFU for all medical devices for professional use, in particular to counteract unnecessary resource consumption. This is substantiated by MTE by a survey of users of medical devices in the EU.
The results of the survey by MTE reflect at European level what was already determined in our German survey on the use of eIFU for medical devices by MedicalMountains GmbH and SPECTARIS in autumn 2021: for a wide variety of reasons (usability, hygiene aspects etc.) the use of electronic instructions for use.
Medical Mountains GmbH and SPECTARIS would like to further promote this topic politically and are therefore conducting this joint survey among German manufacturers of medical devices. Answering the questions takes about 5-10 minutes:
This link takes you to the survey!
The survey is open until June 30, 2023. Thank you for your support!
