Instructions for use (IFU) are the interface between the manufacturer and the user. They must enable a qualified user to use the device safely within its intended purpose. Section 23.4 of Annex I to the MDR lists the information that the IFU must contain.
The mandatory content of the IFU
Section 23.4 lists 28 headings (points a to ab). The main ones to keep in mind.
The name or trade name and registered place of business of the manufacturer and of the EC REP authorised representative for manufacturers established outside the EU.
The intended purpose of the device, including the expected results and the target patient populations. The indications and contraindications must be clearly identified.
All contraindications, warnings and precautions to be taken, including potential interactions with other devices, medicinal products or known substances.
The expected performance and known or foreseeable undesirable side effects.
Instructions for installation, commissioning, use, maintenance, servicing, cleaning and disinfection. For reusable devices, the maximum number of permitted reuses where applicable.
For single-use devices: the explicit prohibition of reuse and the risks associated with unintended reuse.
For sterile devices: the indication of the sterile state and the action to be taken in the event of damage to the sterile packaging.
Date of issue of the instructions for use or of their latest revision, and version number (point y).
A notice that any serious incident must be reported to the manufacturer and to the competent authority of the Member State (point z); for software, minimum requirements concerning hardware, IT networks and IT security (point ab). The batch or serial number and the use-by date belong to the label (Section 23.2).
When the IFU may be omitted
Section 23.1(d) of Annex I provides for a limited derogation: instructions for use are not required for Class I and IIa devices that can be used safely without them, unless otherwise provided elsewhere in Section 23. The manufacturer must document and justify this decision in the technical documentation.
This derogation is more restrictive than it appears, and it should not be confused with electronic instructions for use: supplying the IFU in electronic form rather than on paper falls under a separate regime (Section 23.1(f) and Implementing Regulation (EU) 2021/2226), reserved for certain devices.
Common mistakes in IFU
IFU not updated after a device modification. Any modification affecting the indications, contraindications, warnings or instructions for use must be reflected in the IFU before the modified version is placed on the market.
Language not compliant with the market. IFU provided only in English on the French market constitute a non-compliance with Article 10(11), which refers to the languages set by each Member State. English is not an official language in France.
Insufficient safety information on foreseeable misuse. The IFU must cover the risks associated with foreseeable misuse, not only the conditions of correct use. This point is frequently inadequate in SME files.