The Instructions for Use – More Than Just a Requirement

The instructions for use represent the direct interface between the manufacturer and the user. This document therefore carries particular significance under the MDR.

Terminology

Engagement with the instructions for use begins with the correct terminology. The MDR defines "instructions for use" in Article 2(14) as "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." The standard abbreviation is "IFU." Alternative terms such as "user manual" or "usage information" should therefore be avoided.

Obligation to Provide

It is among the general obligations of the manufacturer to make product information available (MDR, Article 10 and Annex I, Section 23). The content and readability must be appropriate for the intended user – whereby the term "readability" certainly also encompasses "comprehensibility."

An exception applies to Class I and Class IIa devices. For these products, the instructions for use may be dispensed with under the MDR if the devices are self-explanatory and it can be assumed that the user is familiar with their safe use. This may apply to simple products or instruments that form part of the everyday practice of a treating physician. It should also be noted, however, that instructions for use may contain important information – for example, regarding reprocessing.

For medical devices intended for lay use, more extensive information is required. In such cases, there is a strong argument for a mandatory set of instructions for use.

Clinical Evaluation

The clinical evaluation reflects the risk profile of the medical device and includes, as an essential component, the comparison of the information contained in the instructions for use against the current state of science. Information that must be included in the instructions for use includes the intended purpose, with precise specification of the indications, contraindications, the intended patient group, and the intended user.

For generic products used in a non-specific, general patient population, this level of detail may appear somewhat excessive. Nevertheless, this information must be made fully available to the user, as the clinical evaluation must incorporate it into the assessment of the benefit-risk ratio of the medical device. This also applies to residual risks, contraindications, and potential complications, which must be communicated to the user (and the patient) in the form of restrictions, precautions, and warnings. Here too, the clinical evaluation verifies the alignment of the instructions for use with the current state of science.

The instructions for use, the risk analysis, and the clinical evaluation must be consistent with one another.

In our experience, quantitatively specified conditions of use – such as a defined duration of application or a specific dosage – should also be carefully scrutinized. Such information must be reconciled with the clinical evaluation and must be consistent with the current state of science.

Promotional Claims

Closely linked to the instructions for use is the promotional presentation of the product. How is the product advertised on the website and in brochures? The claims made there regarding performance, safety, indication, and intended user must a) be substantiated and b) be consistent with the information in the instructions for use. Such promotional claims sometimes take on a life of their own and cannot be adequately supported by the current state of science or by technical testing. Experience shows, however, that it is precisely such promotional claims that tend to attract scrutiny from Notified Bodies. Article 7 of the MDR explicitly prohibits the use of misleading information in the instructions for use and in advertising with respect to the intended purpose, safety, and performance of the device.

Vigilance and Risk Analysis

In addition to informing the user or patient, it is also necessary – from a reporting perspective – to incorporate all identified risks and potential complications that have been identified within the clinical evaluation and discussed within the risk analysis into the instructions for use. This equally applies to the risk-reducing measures defined in the risk analysis, which may take the form of information, a warning, or a restriction directed at the user or patient. Such measures must not be lost at the interface between risk management and the instructions for use.

Of particular relevance in this context is Article 87(1)(a) of the MDR, which addresses the reporting of serious incidents in connection with devices made available on the Union market. The reporting obligation does not apply where an incident constitutes an "expected side effect" that is already clearly documented in the product information (i.e., the instructions for use). Furthermore, "expected side effects" must be quantified in the technical documentation – specifically in the risk analysis and the clinical evaluation – and must be the subject of trend reporting.

Conclusion

• In the course of transitioning to the regulatory framework of the MDR, a revision of the instructions for use will in many cases be necessary in order to comply with the extensive requirements of Annex I.
• It must be ensured that the information in the instructions for use is "in phase" with the clinically relevant parts of the technical documentation: the information, measures, and precise wording (regarding intended purpose, indications, contraindications, patient population, intended users, warnings, potential complications, etc.) must be consistent across all parts of the technical documentation.
• There are numerous interfaces with the clinical evaluation, risk management, usability, and the vigilance system.
• The information contained in the instructions for use regarding use, intended purpose, indications, contraindications, patients, users, warnings, risks, etc. must be substantiated by the current state of science and/or clinical data.
• Marketing claims form part of the technical documentation and must likewise be aligned with the clinical evaluation and the instructions for use.