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:
“means 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;”
“package insert; portion of the accompanying information that is essential for the safe and effective use of a medical device or accessory directed to the user of the medical device”
“General and technical information provided by the manufacturer to inform the user of the medical device or IVD medical device’s intended purpose and proper use and of any contraindications, warnings, or precautions to be taken. It is provided by the manufacturer to support and assist the device users in its safe and appropriate use.”
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:
All stand for the same.
Numerous laws, ordinances, directives, standards and other regulations establish requirements for instructions for use. These include:
Most of the requirements for the instructions for use can be found in Annex I, Section 23.
Most of the requirements for the instructions for use can be found in Annex I, Section 20.
Regulation 2021/2226 governs the conditions under which instructions for use may be made available electronically (eIFU) and the associated requirements. The regulation is currently being revised to allow eIFUs also for lay users of software devices (see here).
The instructions for use are part of the user interface. Therefore, they must be developed following a usability engineering process according to IEC 62366-1.
Section 7.9 specifies what has to be included in instructions for use for medical electrical equipment.
ISO 20417 replaces EN 1041 and, in section 6.6 in particular, establishes requirements for instructions for use.
ISO 18113-(1-5): In vitro diagnostic medical devices — Information supplied by the manufacturer
– Part 1: Terms, definitions and general requirements
– Part 2: In vitro diagnostic reagents for professional use
– Part 3: In vitro diagnostic instruments for professional use
– Part 4: In vitro diagnostic reagents for self-testing
– Part 5: In vitro diagnostic instruments for self-testing
Parts 1-5 of ISO 18113 specify the requirements that IVD instructions for use must meet.
The aim of this IMDRF/GRRP document is to establish internationally harmonized requirements for labeling (including instructions for use).
The FDA has a series of requirements for the instructions for use; in 21 CFR part 801 for medical devices and in part 809 for IVDs.
Medical device manufacturers should follow this guidance for device clearing in the USA. It also provides helpful tips for writing instructions for use outside the USA as well.
Analogous to 62366-1, manufacturers should follow this guidance when writing instructions for use for the US market.
a) Best practice guides for creating instructions for use
Other standards and guides provide advice on how to write good instructions for use:
See sections 4 and 5 for more information on the content of these guidances
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:
“Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.”
Evidence that the device can be used safely even without the instructions for use can be provided in two ways:
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:
“Instructions for use shall be provided together with devices. However, in duly justified and exceptional cases instructions for use shall not be required or may be abbreviated if the device can be used safely and as intended by the manufacturer without any such instructions for use.
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:
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.
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.
Read more on the subject of electronic instructions for use and Regulation 2021/2226 here.
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:
“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.”
If we summarize the requirements of the regulations mentioned above, we find that the main contents required are:
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.
Contact our consultants for an up-to-date list of language requirements for instructions for use and labeling for medical devices and IVDs within the EU.
In Germany, the Medizinproduktedurchführungsgesetz regulates the language issue:
8(2) “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, provided this information is intended exclusively for professional users and the safety information is also provided in German or in the user's language.”
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).
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:
“In particular, instructions for use shall be written in terms readily understood by the intended user [...].”
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:
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.
The translation service provider should have experience in the field of medical devices, a certified quality management system according to ISO 9001:2015, ISO 17100:2015 or ISO 13485:2016, and also specialize in instructions for use within the scope of the MDR/IVDR.
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.
Find out more about the usability engineering process according to 62366-1 in our blog articles IEC 62366-1:2015 Usability Standard News and Summative Evaluation:What You Need to Pay Attention to.
In addition, both IEC 82079-1 and AAMI TIR 49 provide specific recommendations for establishing a process for creating the instructions for use.
The process for creating the instructions for use should include the following steps:
The process should be applied iteratively. In other words, an evaluation should be carried out at important milestones and the results of the evaluation should serve as input for further development.
Time and time again, in dozens of usability tests, our consultants have seen use errors resulting from inadequate instructions for use. Problems in usability tests caused by inadequate instructions for use can delay device authorization.
If your device has already been placed on the market with inadequate instructions for use, in the worst case they could lead to harm to patients, users or third parties.
Don’t leave the writing of instructions for use to developers or product managers who are not trained for this. You need specialized authors, editors, translators, proofreaders, illustrators and reviewers.
Instructions for use are not intrinsically good or bad. They must be written for the users specified in the intended purpose. Instructions for use for medical professionals will not be the same as those written for lay people or those written for service technicians.
You should write down the goals you want to achieve with the instructions for use. What use errors and therefore which risks do you want to minimize? Which tasks does safe use have to be ensured for?
Consistent presentation makes reading easier. Editorial guidelines should make sure that the instructions for use contain the following:
When designing instructions for use, you should at least:
Manufacturers often write instructions that don’t explain actions clearly enough.
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.
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:
The Johner Institute often reviews instructions for use as part of formative and summative usability evaluations.
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.
The experts at the Johner Institute in Frankfurt and Washington D.C. can help you with advice and templates for writing and reviewing instructions for use, including English-language ones. Please get in touch with us.