Instructions for use (IFU) of medical devices - safety and efficacy

2021-06-29

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On 26 May 2021, Regulation (EU) 2017/745 on medical devices (MDR) entered into force.

CE marking requirements for sale in EU markets make the process of conformity assessment and post-market surveillance more rigorous, always with the goal of enhancing safety for medical device users.

The manufacturer and/or agent must communicate, in each country’s official language, information on the intended use, precautions and hazard warnings.

Instructions for use (IFU) are essential documents for a medical device’s safety and efficacy, and must be:

  • Legible
  • Indelible
  • Understandable
  • Safe
  • Adapted to the device’s intended user

What must be taken into account when writing or translating instructions for use which are legible, understandable and adapted?

Legibility

A text is considered legible when the reader can quickly and easily recognize and decipher its written characters, i.e. how quickly and easily the letters can be read. Parameters such as cut, serif and sans-serif typography, contrast, colour, weight, body (size) and height contribute towards a text’s legibility. The manufacturer and/or importer must keep these in mind in the graphic design of labelling/instructions for the use of medical devices.

Indelibility

The text cannot be erased, or easily erasable, but instead must be indelible and clear so that users can easily read it.

For better accessibility, the directive requires instructions for use for medical devices to be available online in an electronic version (e-IFU), normally in PDF format, and constantly updated.

Understandability

A text is understandable if the reader can easily grasp its meaning. To this end, factors such as consistency, punctuation, clarity, conciseness and vocabulary are important.

For example, words easily understandable by both healthcare professionals and everyday users should be chosen, together with short sentences. This will ensure the proper use and care of medical devices.

Safety

Information shown on labelling and in instructions for use should help to protect people. In addition to avoiding inaccuracies, omissions and other shortcomings, information should warn users of any risks involving the device’s use. The manufacturer and/or agent should provide all pertinent warning messages to keep users safe.

Adapted to the device’s intended user

The medical device should be used according to the instructions for use, which should be appropriate to the user.

Adapting information begins with the language, which should be the official language of the member state where the device is being marketed. In addition, it should be localized for the country (e.g. units of measurement) for safe and effective use.

This localization also includes the product name, which should not cause misunderstandings or in any way be derogatory in the country’s official language.

In summary, the wording of instructions for use for a medical device is of the utmost importance in user safety. The manufacturer and/or importer must consider technical requirements, such as the printing process and materials, and linguistic requirements (language, terminology, conciseness, clarity) so that users can make use of and maintain the device in complete safety for its intended purposes.


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