Instructions for use: digital or analog?

Category: product liability, product safety Industry: healthcare Author: Year:
Miriam Schuh

The term "instructions for use" refers to information provided by the manufacturer to inform the user of a device's intended purpose and proper use, as well as any precautions to be taken (Article 2 No. 14 of Regulation (EU) 2017/745 on medical devices (the MDR) (PDF). In particular, devices' labeling and instructions for use may not use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance (Article 7 of the MDR). The instructions for use are provided together with the device itself.

When instructions for use may be dispensed with

In accordance with Annex I to the MDR (PDF)(General Safety and Performance Requirements), Chapter III (Requirements regarding the information supplied with the device) No. 23.1 (d), instructions of use are not required, by way of exception, "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." 

In other words:

  • Instructions for use are generally required.
  • Instructions for use may only be dispensed with in exceptional cases.
  • Such exceptional cases only apply for Class I and Class IIa medical devices.
  • Instructions for use are mandatory for devices in a higher risk class.

If the manufacturer would like to contend that instructions for use are not required, i.e. that an exception applies, it must first demonstrate that it can dispense with the instructions for use in this particular case without endangering the safety of users, patients or third parties because safe use of the device is assured even without instructions. In addition, instructions for use may only be dispensed with if the device in question is used exclusively by persons exercising their profession in the course of providing professional health care services. There must be no reasonable expectation that the device may be used by other persons.

The question as to whether instructions for use may be dispensed with is to be considered within the context of risk management. It is necessary to assess and evaluate the risks which may be undergone if instructions for use are absent and reasons must be provided in support of the decision to dispense with instructions for use. 

Digital instructions for use

Article 3(1) of Regulation (EU) No. 207/2012 (PDF) on electronic instructions for use of medical devices (the Regulation) contains a complete list of devices for which electronic instructions for use are sufficient.

In particular, this includes the following devices:

  • active and inactive implantable medical devices and accessories which are intended to be used exclusively for the implantation or programming of a defined active implantable device;
  • fixed installed medical devices;
  • medical devices and accessories which are fitted with a built-in system visually displaying the instructions for use; and
  • stand-alone software.

All medical devices other than those specified above still require instructions for use in analog form, except for cases in which instructions for use may be dispensed with entirely.

There are also other conditions for providing electronic instructions for use instead of paper instructions. For example, the risk assessment must conclude that the safety level with electronic instructions for use is at least as high as if instructions for use were provided in paper form. In addition, the manufacturer must have a system which allows the manufacturer to provide the user with instructions for use in paper form in a timely manner, free of charge. There are also additional requirements for change management and with respect to the time frame for providing the digital instructions.

Summary and recommendation

Manufacturers of Class I and Class IIa devices may have the option of dispensing with instructions for use. The risks of doing so must be weighed carefully, and the reasons for this course of action are to be explained as part of the manufacturer's risk management system. The manufacturer could be liable for any injuries to users or patients resulting from the decision not to provide instructions for use.

Instructions for use may be provided electronically, rather than in paper form, in just a limited number of cases. Manufacturers which choose to provide instructions for use in digital form are required to meet certain additional requirements.

[November 2020]