The importance of instructions for use for medical devices is often underestimated, although the contents are regulated in detail in the relevant legislation. In this article, we explain the legal as well as normative requirements for instructions for use and take a look at the special content for (AI-based) software.
Legal requirements for the instruction manual
In Art. 2 (14) of the Medical Device Regulation (MDR), the essential tasks of the instructions for use are to communicate to the user the intended purpose of the product and its correct use, as well as "any precautions to be taken". These "precautions" refer to the third possibility of risk control measures in the context of risk management, namely the "safety information (warnings, precautions, contraindications)" (No. 4 c) Annex I MDR).
The instructions for use are part of the technical documentation of a medical device (No. 2 Annex II MDR) and thus of the conformity assessment procedure. It is mandatory for all medical devices, unless the narrowly defined exemption for certain class I and class IIa devices in No. 23.1. d) Annex I MDR applies.
Detailed requirements on the content of the instructions for use can be found in section "23. Labeling and Instructions for Use" of Annex I MDR. Compared to the old European regulatory framework, these requirements have become much more detailed! The contents include:
- Product name, manufacturer name and contact details,
- Intended use (incl. indications, contraindications and target patient population),
- Product description (including information on clinical benefits and performance characteristics),
- Minimum requirements for environment of use,
- residual risks and warnings,
- etc.
“The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.” (No. 22.1. Annex I MDR).
Furthermore, Art. 7 MDR stipulates that the instructions for use must not contain any misleading information about the product and that expected risks must not be concealed. It is therefore essential that the manufacturer ensures consistent statements about his product in the instructions for use and in advertising materials and websites.
The Implementing Regulation (EU) 2021/2226, published in 2021, now also allows the provision of electronic instructions for use for software (Art. 3 (3)). Otherwise, electronic instructions for use are possible instead of the paper form for:
- professional users, provided that use of the product by other persons is not to be expected (Art. 3 (2)) as well as
- implants, permanently installed medical devices/accessories and medical devices/accessories with a built-in system for displaying the instructions for use (Art. 3(1)).
Paragraph 8 (2) in the German Medical Device Law Implementation Act (MPDG) regulates the language requirements for instructions for use as follows: (free translation from German to English)
Devices may only be supplied to users and patients within the scope of this law if the information intended for users and patients is provided in German. In justified cases, the information may also be provided in English or another language easily understood by the user of the medical device if this information is intended exclusively for professional users and the safety-related information is also provided in German or in the language of the user.
If the product is on the market, the manufacturer is obliged to update the instructions for use within the framework of post-market surveillance if this is a measure resulting from the data collected (Art. 83 3 b) MDR).
Where can I find more detailed information on the preparation of instructions for use for medical devices?
Although the requirements for instructions for use for medical devices are set out in sufficient detail in the relevant legal texts, a number of standards support the manufacturer in meeting the requirements with further details:
- ISO 20417 "Medical devices - Information to be supplied by the manufacturer" has recently been published, which provides detailed assistance. Section 9 lists the contents of the instructions for use and the technical description and defines the requirements for an electronic form.
- For stand-alone medical device software, specific requirements for the contents of the instructions for use and technical description can be found in section "7.2 Accompanying documents" of EN 82304-1 "Healthcare software - Part 1: General requirements for product safety". The technical description can be prepared separately or as part of the instructions for use.
- Section "7.9.2" and Table C.5 of EN 60601-1 "Medical electrical equipment - Part 1: General requirements for safety including essential performance" provide detailed requirements for the content of the instructions for use for medical electrical equipment and systems.
- EN ISO 15223-1 "Medical devices - Symbols to be used in the labelling of medical devices, marking and information to be supplied - Part 1: General requirements" specifies internationally recognized symbols for medical devices that can be used to mark the product itself, on the packaging or in the accompanying information (e.g. instructions for use). This standard has been harmonized for the MDR. Please note that the manufacturer must provide information on the meaning of pictures, symbols, warnings and abbreviations in the instructions for use (No. 23.1. h) Annex I MDR).
- With regard to suitability for use according to EN 62366-1 "Medical devices - Part 1: Application of suitability for use to medical devices", the instructions for use also play an important role, as it must be demonstrated that the user can understand and implement the contents.
For in vitro diagnostic devices, parts 1-5 of EN ISO 18113 describe specific requirements for manufacturer information.
Special requirements for AI-based software
Neither in the MDR nor in the MPDG do we find specific requirements for the instructions for use of AI-based software as a medical device. However, the product description should include a general description of the algorithm/model. The specifications required by the user for proper use of the product should describe the necessary characteristics of the input data (e.g., format and quality) and identify factors that may negatively affect the quality of the results.
In the draft European Artificial Intelligence Act (AIA), on the part of the legislator, reference is made to the special role of the instructions for use in recital 47: "To address the opacity that may make certain AI systems incomprehensible to or too complex for natural persons, a certain degree of transparency should be required for high-risk AI systems. Users should be able to interpret the system output and use it appropriately. High-risk AI systems should therefore be accompanied by relevant documentation and instructions of use and include concise and clear information, including in relation to possible risks to fundamental rights and discrimination, where appropriate." Articles 13 and 15 of the AIA detail requirements for instructions for use that would also apply to medical devices. The following contents would have to be described:
- Characteristics, capabilities, and performance limitations of the AI system (e.g., intended purpose, level of accuracy, robustness and cybersecurity, known or foreseeable circumstances leading to risks to health and safety or fundamental rights, system performance, input data specifications, and description of expected output)
- Pre-determined changes to the AI system and its performance (if required).
- measures for human supervision of the AI system
- required hardware resources, expected lifetime, and maintenance measures
The IG-NB questionnaire "Artificial Intelligence in Medical Devices" contains a total of 15 requirements for the instructions for use, but not all of them are AI-specific.
We have created a template for the technical description of AI-based software, which you can download free of charge.
What is the basic procedure for creating the instructions for use?
From our consulting experience, we can recommend the creation of a checklist that contains the requirements from the legal texts and the standards used. This ensures that no essential content is missing from the instructions for use and that there are no unpleasant surprises during audits by the notified body or the competent authority.
