Instructions for Use for Medical Devices and IVDs in the EU

Poor instructions for use are a common cause of use errors that can result in harm to patients and users. Furthermore, instructions for use for medical devices and IVDs are subject to strict regulatory requirements. The MDR, the IVDR, the FDA and numerous standards establish specific requirements for the instructions for use.

This article will explain how to write instructions for use that:

• help prevent harm to patients, users or third parties,fulfill all relevant regulations and, therefore, pass the audit.
• are user-friendly and, therefore, increase customers satisfaction and your market success.

1. Definition and synonyms

As you can see, instructions for use are generally printed documents accompanying the device intended to inform the user of the intended purpose, safety information and correct use.

The following terms are often used synonymously:

• Directions for use
• Manual or user manual
• Operating manual
• User guide

All stand for the same.

2. Regulatory requirements for instructions for use

Numerous laws, ordinances, directives, standards and other regulations establish requirements for instructions for use. These include:

a) Best practice guides for creating instructions for use

Other standards and guides provide advice on how to write good instructions for use:

• IEC/IEEE 82079-1: IEC/IEEE 82079-1 (the successor to DIN EN 62079) is as comprehensive as it is practical. Even though this standard is not focused on one particular sector, it applies to medical devices as it is the state of the art for preparing instructions for use.
• AAMI TIR 49: In contrast to 82079-1, AAMI TIR 49 focuses on medical devices and provides guidance for the “Design of training and instructional materials for medical devices used in non-clinical environments.”
• ANSI Z535: ANSI Z535 specifies how safety information should be designed, for example how symbols and colors should be used.
• The WHO Guidance: Designing instructions for use for in vitro diagnostic medical devices also provides valuable tips on how to prepare instructions for use for devices that are not IVDs. It even provides a structure and contains text templates.

See sections 4 and 5 for more information on the content of these guidances

b) When instructions for use are required and when they are not

MDR requirements

The Medical Device Regulation (MDR) permits to provide no instructions for use  under certain circumstances (see Figure 1). In Annex I, Section 23.1(d), it states:

According to the IVDR

Similarly, instructions for use are also not required under certain conditions for IVDs (see Figure 2). However, unlike the MDR, the IVDR does not make this exemption dependent of the class of the device. In Annex I, Section 20.1(d), the IVDR states:

c) How should the instructions for use be provided and in what quantity?

As a general rule, the instructions for use must be provided in paper form. Exceptions are possible under certain conditions (see section 5d).

MDR and IVDR both require the instructions for use to be provided with the device.

If the manufacturer supplies several products to a single user and/or location, a single copy of the instructions for use is sufficient if the following conditions are met:

• The provision of only one copy of the instructions for use has been agreed in advance with the buyer and
• Copies can be delivered at any time on request and free of charge.

Providing only one copy of the instructions for use is permitted under the same conditions under the IVDR. The prerequisite is that the devices are not for self-testing or point-of-care testing.

Instructions for use do not have to be one (bound) document. In some cases, it may even be better to split the instructions for use into several documents, e.g., into one version specifically for non-professionals and one for professional users or service technicians.

d) Provision as electronic instructions for use (eIFU)

Under the MDR, the manufacturer has the option of providing the instructions for use in electronic form only. Regulation 2021/2226 on electronic instructions for use specifies when instructions for use can be provided in electronic form instead of in paper form.

EU Regulation 2021/2226 on electronic instructions for use does not apply to IVDs. Instead, Annex I, Chapter III, Section 20.1(f) of the IVDR regulates when manufacturers do not have to provide the IFU in paper format:

f)  Language requirements of instructions for use

Article 10(11) of the MDR and Article 10(10) of the IVDR require the instructions for use to be provided in one or more of the official language(s) of the target country.

For example, in Belgium, the instructions for use must be provided in German AND Flemish AND French.

The notified bodies have provided a helpful list of which languages are required/permitted in which countries. You can download this list here (as a Word file!). Unfortunately, the website is very unreliable, so you can also find a list of languages permitted for instructions for use here. The list from the notified bodies is from 2008 and therefore might not be up to date in some respects. It refers to the MDD (93/42/EEC). So, there may be different language requirements for IVDs.

In Germany, the Medizinproduktedurchführungsgesetz regulates the language issue:

In Switzerland, the instructions for use must always be provided in German AND French AND Italian, regardless of the language area. They can be provided to professionals in fewer than the three official languages or in English provided that the professional agrees and no risks result from this (see MepV Art. 16).

g) Requirements for the translation of instructions for use

Neither the MDR nor the IVDR establish any explicit requirements for the translation of the instructions for use. However, the instructions for use must be comprehensible for the intended users in all target languages. Annex I, Section 23.1(a) of the MDR states:

This places special demands on the translation of the instructions for use from the original language to the target language.

IEC/IEEE 82079-1 and the quality standard for translation service providers ISO 17100:2015 establish requirements for the translation process and linguists. For example, the linguist should have the following skills:

• They should have theoretical knowledge and practical experience of translating medical texts.
• They should be fluent in the original language.
• They should be a native speaker of the target language.
• They should have a certain minimum experience in the field of the text to be translated and must be familiar with the product-specific terminology.

The requirement that the linguist is a native speaker of the target language is likely to be difficult for manufacturers to meet by themselves given there are 24 official languages in the EU. So, we recommend using translation service providers.

3. Process of preparing the instructions for use

IEC 62366-1 and the FDA's “Human Factors Engineering” guidance require a process for developing a user interface (UI). The instructions for use are an integral part of the user interface. Therefore, manufacturers must also apply the usability engineering process to the instructions for use. This means conducting usability testing of the instructions for use with representative users.

Tip 4: Understand IFUs as a (continuous) process

Writing instructions for use is a team sport with a lot of steps that have to be defined and planned.

Just like the device, instructions for use must be continuously improved.

Tip 5: Follow ISO 14971, IEC 62366-1 and the FDA guidance document “Human Factors Engineering”

The instructions for use are part of the device. Therefore, they are subject to the regulatory requirements governing usability. IEC 62366:2006 even has a separate section on accompanying documentation.

IEC 62366-1:2015 requires these materials to be treated in the same way as the device itself. This means their usability and the effectiveness of the actions they describe – in this case in the form of guidance in the instructions for use – also have to be evaluated.

Professional companies combine several methods:

• Usability tests / participant observations
• Questionnaires
• Self-assessments
• Expert opinions, inspections, review by experts
• Analysis of feedback on previous versions of the instructions for use

The Johner Institute often reviews instructions for use as part of formative and summative usability evaluations.

6. Conclusion

Writing instructions for use requires the same level of professionalism as developing the device itself. The job should not be seen as a necessary evil and quickly palmed off to people who are not sufficiently qualified for it.

The MDR, IVDR and certain standards set requirements for the information the instructions for use must contain; specific guidance on how to write usable instructions for use can be found in other standards such as IEC 82097-1 or AAMI TIR 49.

It is essential that manufacturers remember that instructions for use have to be tested in the same way as other risk-minimizing actions, particularly those relating to usability. This means instructions for use should also be evaluated as part of the formative and summative usability evaluations as per IEC 62366-1.