Under the MDR 2017/745, electronic Instructions for Use (eIFUs) are allowed for the following types of medical devices:
Certain conditions apply, e.g., manufacturers must provide a paper copy of the IFU upon request.
See Commission Implementing Regulation (EU) 2021/2226 for more information.
In February 2024 MedTech Europe, along with 11 other organizations, asked the Medical Device Coordination Group (MDCG) to consider extending the scope of Regulation 2021/2226. The joint statement and fact sheet are available here.
Some of arguments presented were:
“…data collection surveys…from which clear messages emerged regarding the preference for an electronic format IFU:
“…the numerous and compelling advantages of eIFU over paper-based instructions:
Further, in February 2024 a request was posed to the EU Commission, to expand the scope of medical devices eligible for eIFUs.
The Commission’s response, published April 2024, was that eIFUs would be considered as part of the Commission’s overall evaluation of the MDR. Particularly since the evaluation will pay special attention to the “costs and administrative burden stemming from the implementation of legislation, especially for small and medium-sized enterprises”.
The EU Commission initiated a new survey on eIFUs. It is available here.
The purpose is to collect feedback on allowing the use of eIFUs for all professional use medical devices. Note that the survey is targeted to “…healthcare professionals and or other persons working in or employed by a healthcare institution in the European Union…”, and not to industry in general.
It starts today (August 1) and closes on Friday, 11 October 2024.