European Commission Launches Survey on eIFUs for Professional Use Medical Devices
The European Commission has launched a survey on Electronic Instructions for Use, or eIFUs, for medical devices.
The survey states that the Commission is currently considering allowing the use of eIFUs for all professional use devices, meaning devices used by healthcare professionals.
Target Audience
The survey is addressed to healthcare professionals and other persons working in or employed by a healthcare institution in the European Union.
The Commission states that feedback from these stakeholders will be essential to support the decision-making process of EU medical device regulators.
Survey Timeline
The survey started on 1 August 2024 and is scheduled to close on 11 October 2024.
The form also notes that the estimated time required to complete the survey is less than 5 minutes and that it is available in all EU languages.
Key Topics Covered
The survey asks respondents about their professional role, institution, EU Member State and how often they consult medical device instructions for use.
It also asks whether respondents have internet access at work, whether they currently use paper IFU, electronic IFU or both, and whether they would prefer eIFUs if available.
Reasons for Paper or Electronic IFU Preference
The survey explores why some users may prefer paper IFU, including lack of training, SOP requirements, unstable internet access, lack of devices to view eIFU, data privacy concerns, language availability and the physical availability of paper IFU with the product.
It also asks why users may prefer eIFUs, including easier storage and access, easier search and navigation, easier access to the latest version, availability anywhere, multiple languages, SOP requirements, hygiene reasons and waste reduction.
Paper IFU Storage, Disposal and Workplace Policies
The survey 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.
A later section also asks about workplace SOPs, paper IFU storage policies, disposal routes, estimated percentage of paper IFUs disposed of each year, and whether the workplace is charged for paper disposal.
Possible Expansion Beyond Professional Use Devices
The survey also asks whether respondents agree that eIFUs could be provided instead of paper IFUs for other medical devices intended for lay users, such as devices where a healthcare professional trains the lay user.
Possible responses include expanding eIFUs to all medical devices, limiting expansion to devices where a healthcare professional trains the lay user, or not expanding eIFUs beyond professional use devices.
Impact on Medical Device Manufacturers and Healthcare Institutions
For medical device manufacturers, healthcare institutions, notified bodies and regulatory teams, the survey is relevant because it signals continued EU attention to digital IFU access, user preferences, workplace readiness and sustainability considerations.
Stakeholders should pay particular attention to:
possible expansion of eIFU use for professional use devices;
healthcare professional access to electronic information;
internet availability in clinical settings;
SOP references to paper or electronic IFU;
language availability;
data privacy concerns;
availability of the latest IFU version;
paper IFU storage and disposal practices;
waste reduction and sustainability;
potential future discussion on lay-user devices.
For companies placing medical devices on the EU market, the key message is that eIFU policy discussions should be followed closely, especially where product information, labelling strategies, user access, multilingual content and healthcare institution workflows are affected.
