Electronic Instructions for use: survey

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions.

For more information, visit www.medtecheurope.org

The EU Regulation 2021/2226 allows Instructions for use (IFU) for certain medical devices such as (active) implantable or software to be delivered in electronic format. For devices covered by the EU regulation 2021/2226 it is always possible to request a paper copy free of charge.

Many manufacturers already provide IFU in electronic format in addition to paper.

Electronic Instructions for use for professional use (i.e. accompanying devices that are used by healthcare professionals) as a default format are already common worldwide with major jurisdictions, such as United States, Canada, Brazil, Australia and others.

We would like to have a few minutes of your time to understand your preferences regarding the format of IFU.

Please note the following abbreviations:

·        IFU – instructions for use

·        eIFU – electronic Instructions for use. This is understood to mean that they are delivered via a website (link or QR code), USB or other electronic (non-paper) means.

·        Paper IFU – Instructions for use in paper (physical) format.

The individual responses collected, on top of being anonymous, will be deleted once the survey is finalised and the aggregated data is compiled. The aggregated data may be used in MedTech Europe outputs.