Technical documentation section 2. Information supplied with the device:
2.2 Instructions for use (IFU) under MDR
Under the MDR, the instructions for use (IFU) must provide comprehensive, clear, and accessible information to ensure the safe and effective use of a medical device. According to Annex I, Section 23.4, the IFU must include:
- basic identification and purpose: clear indication of the intended purpose, target patient group(s), users, indications, contra-indications, and expected clinical benefits (where applicable);
- performance and compatibility: details on performance characteristics, any compatibility requirements with software or accessories, and information for proper selection and verification of use;
- risk and safety information: residual risks, undesirable side effects, contraindications, and necessary warnings or precautions, including guidance on what should be conveyed to patients;
- preparation and use: instructions for any necessary preparation steps (e.g., sterilization, calibration), maintenance schedules, replacement of consumables, and information on reuse and disposal;
- installation and maintenance: guidance for correct installation and ongoing safe performance, including preventive maintenance, calibration, and protective measures during servicing;
- reuse and single-use: reuse criteria, reconditioning requirements, and risks associated with reusing single-use devices;
- combination use: specifications for use with other devices or general-purpose equipment, including compatibility and restrictions;
- radiation and substances: if applicable, detailed data on emitted radiation and precautions related to hazardous substances, such as CMR or endocrine-disrupting compounds;
- specific device types:
- implantable devices: material exposure details;
- software or electronic devices: minimum IT and cybersecurity requirements;
- devices absorbed / dispersed in the body: interaction risks, side effects, and overdose information;
- patient-specific information: circumstances when lay users should consult healthcare professionals, and required information for implanted devices;
- administrative details: date and version of the IFU, reporting obligations for serious incidents, and national language/local requirements if no IFU is provided in the packaging.
The IFU plays a central role in ensuring compliance with the general safety and performance requirements of the MDR and must be kept up to date and readily available to users and patients when necessary.
