European Commission Launches Survey on Electronic Instructions for Use for Medical Devices
The European Commission is considering allowing the use of Electronic Instructions for Use, or eIFUs, for all professional-use medical devices.
The survey is addressed to healthcare professionals and other persons working in or employed by healthcare institutions in the European Union. Their feedback is intended to support the decision-making process of EU medical device regulators.
Survey Timeline and Accessibility
According to the survey document, the questionnaire is estimated to take less than five minutes to complete.
The survey is available in all EU languages and started on 1 August 2024, with a closing date of 11 October 2024.
Focus of the Survey
The survey explores how healthcare professionals currently use medical device Instructions for Use, including whether they consult paper IFUs, electronic IFUs or both depending on the situation.
It also asks whether respondents have internet access at work and whether they would prefer using electronic instructions for use if available.
Reasons for Paper or Electronic IFUs
The questionnaire asks respondents why they may prefer paper IFUs, including factors such as training, SOP requirements, unstable internet access, lack of devices to view eIFUs, privacy concerns, language availability and the fact that paper IFUs are physically available with the product.
It also asks why respondents use or would prefer electronic IFUs, including easier storage and access, easier search and navigation, easier access to the latest version, availability in multiple languages, hygienic reasons and waste reduction.
Paper IFU Storage, Disposal and Workplace Policies
The survey also includes questions on what users do with paper IFUs after reading them, how often paper IFUs are needed and whether national provisions require institutions to store IFUs or make them accessible at all times.
Additional questions address workplace SOPs, paper IFU storage and disposal policies, estimated annual disposal of paper IFUs and whether the workplace is charged for paper disposal.
Possible Expansion Beyond Professional-Use Devices
The survey also asks whether electronic IFUs could be provided instead of paper for other medical devices intended for lay users, such as devices where a healthcare professional trains the user, including examples such as contact lenses.
This indicates that the Commission is not only collecting feedback on professional-use devices, but also exploring views on whether eIFU use could be expanded to selected lay-user contexts.
Impact on Medical Device Manufacturers
For medical device manufacturers, the survey is relevant because any future expansion of eIFU acceptance could affect IFU strategy, labelling processes, digital access systems and compliance planning.
Manufacturers should pay particular attention to:
eIFU availability for professional-use devices;
paper IFU requirements and possible future changes;
healthcare institution access to internet and devices;
language availability;
access to the latest IFU version;
SOP alignment in healthcare institutions;
usability and searchability of electronic formats;
data privacy concerns;
sustainability and waste reduction;
potential extension to selected lay-user devices.
For manufacturers, the key message is that eIFU policy development remains closely linked to healthcare professional access, usability, safety, language availability and the practical needs of clinical environments.
