The instructions for use (IFU) for medical devices consist of the information provided by the manufacturer to enable the user to use the device safely and effectively according to its intended purpose. Their mandatory content is derived from Annex I, Chapter III, Section 23.4 of Regulation (EU) 2017/745, while the general requirements regarding intelligibility, medium, and provision are set out in Section 23.1. As part of the product information, the IFU belongs to the general safety and performance requirements and is subject to conformity assessment as well as ongoing updates through post-market surveillance. Errors in the instructions for use are therefore regulatory deficiencies and not merely editorial weaknesses.
Provision and Intelligibility
According to Section 23.1, the instructions for use must accompany the device and be easily understood, supplemented by drawings and diagrams where necessary. By way of exception, they are not required for Class I and Class IIa devices if these devices can be used safely without instructions for use. If several devices are supplied to a single user or location, a single copy may be provided in agreement with the purchaser; further copies must be provided free of charge upon request.
Mandatory Content
In addition to selected label information, Section 23.4 specifically requires the intended purpose with indications, contraindications, target patient groups, and intended users, the expected clinical benefits, performance specifications, residual risks including undesirable side effects and information for the patient, as well as details on preparation before use, including sterilization, final assembly, calibration, and disinfection.
Furthermore, requirements for facilities, training, and user qualifications are included, as well as information for verifying proper installation, the procedure for damaged sterile packaging, validated reprocessing instructions for reusable devices with indications of the end of reusability, risk-relevant properties for devices labeled as single-use if reused, warnings and restrictions on use, information on safe disposal, the date of issue or revision number, and the instruction to report serious incidents to the manufacturer and the competent authority.
Special Product Groups
For implantable devices, full qualitative and quantitative information on materials and substances to which patients may be exposed is required, supplemented by the information to be provided to the patient under Article 18. For devices with programmable electronic systems or software, minimum requirements for hardware and network characteristics as well as IT security measures, including protection against unauthorized access, must be specified.
For devices intended for lay users, the circumstances under which a healthcare professional should be consulted must be stated. For devices of the type listed in Annex XVI without a medical purpose, information on the lack of clinical benefit and the risks must be included. For Class III and implantable devices, reference must also be made to the summary of safety and clinical performance according to Article 32.
Electronic Instructions for Use
Section 23.1 allows for non-paper-based provision only under the conditions of the relevant implementing regulations; the text of the Regulation still refers to Regulation (EU) No 207/2012, which has been replaced by Regulation (EU) 2021/2226 for devices within the scope of Regulation (EU) 2017/745. The latter permits electronic instructions for use for, among others, implantable and active implantable devices, fixed installed devices, and devices with a built-in display system, in each case only for exclusively professional use.
A prerequisite is a documented risk assessment with defined checkpoints proving that the level of safety is at least equivalent to that of a paper version. A paper version must be provided free of charge upon request and at the latest within seven calendar days, and the labeling must clearly indicate that the instructions for use are provided electronically and describe the method of access.
Distinction from Summary of Product Characteristics, Package Leaflet, and Summary Report
In the case of medicinal products, the Summary of Product Characteristics (SmPC) and the package leaflet are part of the marketing authorization, are officially approved, and are strictly prescribed in structure and wording; changes require a variation procedure. In contrast, the manufacturer is responsible for the instructions for use of a medical device within the framework of the conformity assessment, without an authority approving the text.
They must also be distinguished from the Summary of Safety and Clinical Performance (SSCP): as a summary document, the latter is addressed to users and patients and is made publicly available via the European database, whereas the instructions for use guide the specific application.
Relevance for clinical trials
In clinical trials, the instructions for use are a safety-relevant trial document because they specify the intended use, user qualification, and warnings against which any deviation in use is subsequently evaluated. The clinical trial plan, investigator’s brochure, and training materials must not contradict them, as otherwise neither protocol deviations nor use errors can be clearly categorized.
After the study is completed, the direction is reversed: findings on handling, residual risks, and usability flow into the update of the instructions for use and labeling, as expressly provided for by post-market surveillance. Full-service CROs like Mediconomics support sponsors and manufacturers in keeping trial documents and instructions for use consistent, systematically recording use errors, and deriving robust text changes from them.
Frequently Asked Questions (FAQ)
Can the instructions for use be omitted entirely?
Only by way of exception for Class I and Class IIa devices, if they can be used safely without instructions for use. The justification must be included in the technical documentation.
Is a purely electronic instruction for use permissible?
Yes, but only for the product groups mentioned in Regulation (EU) 2021/2226 for exclusively professional use, following a documented risk assessment and with a free paper version available upon request.
How often must they be updated?
Whenever findings from risk management, clinical evaluation, or post-market surveillance provide cause to do so. The date of issue or revision number must be stated, and in the case of electronic provision, all previous versions must remain available.
Regulatory References
- Regulation (EU) 2017/745, Annex I Chapter III Section 23.4 — Content of the instructions for use
- Regulation (EU) 2017/745, Annex I Chapter III Section 23.1 — Provision, intelligibility and non-paper format
- Regulation (EU) 2021/2226 — Conditions for electronic instructions for use
- Regulation (EU) 2017/745, Article 18 — Information to be supplied to the patient with an implanted device
- Regulation (EU) 2017/745, Article 32 — Summary of safety and clinical performance
