Glossary · Regulation

Instructions for use

Also known as: IFU, user manualIn Portuguese: Instruções de utilização

Short definition

Instructions for use are the information provided by the manufacturer to inform the user of the device's intended purpose and proper use, and of any precautions to be taken.

In plain language

The definition is in Article 2, point 14, of Regulation (EU) 2017/745, and the required content is set out in Annex I. They include, among other things, indications, contraindications, warnings and cleaning instructions. They are part of the documentation an institution should be familiar with before using the device.

Related terms

Sources

Glossary edited by the RVer team. Definitions are for information and do not replace clinical, legal or tax assessment or advice.Reviewed on 7 October 2026