Instructions for use (IFU)

The MDR and IVDR set out what the instructions must contain. Some lower-risk devices may be supplied without instructions if they can be used safely without them, and electronic instructions are allowed for certain devices.

‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;

EU MDR, Article 2(14)

‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;

IVDR, Article 2(14)

portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory directed to the user of the medical device Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant specialized training. Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a medical device or accessory can be included in the instructions for use. Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or accessory. Note 4 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use are exempted from having instructions for use by some authorities with jurisdiction. Note 5 to entry: See Figure 1. [SOURCE: ISO 20417:2021,[15] 3.11]

ISO 15223-1:2021, clause 3.7

portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory (3.1) directed to the user of the medical device Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant specialized training. Note 2 to entry: For the purposes of this document, instructions for the professional processing between uses of a medical device or accessory can be included in the instructions for use. Note 3 to entry: The instructions for use, or portions thereof, can be located on the display of a medical device or accessory. Note 4 to entry: Medical devices or accessories that can be used safely and effectively without instructions for use are exempted from having instructions for use by some authorities having jurisdiction. Note 5 to entry: See Figure 1.

ISO 20417:2021, clause 3.11