Both the EU MDR and EU IVDR require to perform risk analyses to identify any potential hazard during intended use and reasonably foreseeable misuse.[5] ISO 14971 for the application of risk management to medical devices can be used to meet risk management requirements.

Following a risk management plan, reasonably foreseeable misuse must be considered. This may require manufacturers to look at the internet connection required, environmental temperature and the expertise of the user (a more detailed explanation follows below).

When risks have been thoroughly detected, consulting all (internal) stakeholders, the manufacturer must classify the probability and severity of a risk. Subsequently, adequate controls must be implemented.

When the risks are mitigated, the risk classification is estimated again to identify whether risks are mitigated to an ‘acceptable level’.[6] This level is defined by the manufacturer itself, but is generally defined as a “remote probability of failure occurring” combined with a “very minor inconvenience”.

However, the probability and/or severity of some risks cannot be completely mitigated to an acceptable level. In this case, the manufacturer must argument and document whether the benefits for the patients outweigh the potential risk.

In other cases, risks cannot be completely mitigated because the risk is (partly) outside of the control of the manufacturer. Which may have been the case with Breathomix and the GGD. Nonetheless, the manufacturer must take actions to mitigate the risk as far as possible by, for example, providing trainings and instructions.[7] Furthermore, if the device is intended to be used by lay persons, they should be protected against the risks posed by this medical device.[8]

If there still is unacceptable residual risk, these must be clearly communicated to the user upon use.[9]

The “normal condition of use” is not defined in the EU MDR. This definition can, however, be derived from other information provided by the manufacturer. The EU MDR requires manufacturers to define, among other things, the intended use and to provide instruction of use.

Defining the intended use does not merely entail the intended medical indication, but also the intended user (profile) and patient population, the environment in which the device is intended to be used and the operating principle.[10]

Chapter III of Annex I details what the label and instructions for use of a medical device must contain. They specifically set requirements to inform users on the appropriate use of the device, the residual risks and information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer.

In relation to the Breathomix – GGD case, the instructions for use should include information about the fluctuations of temperature, external influences and/or environmental conditions when these could adversely affect the characteristics and performance.[11],[12] The instructions for use should additionally provide information on how to use the device properly and the intended user. [13],[14]

To give more substance to ensuring the medical device is designed and manufactured in a way that minimizes the risk of human error is to apply a process called: Usability Engineering.[15] This process is intended to identify and minimize use errors and thereby reduce use-associated risks. This process relates to the beforementioned risk management process. IEC 62366-1:2015 provides guidance in the application of usability engineering to medical devices.

The instructions for use must include a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.[16] The latter is in the Netherlands, for example, the Inspectie Gezondheidszorg en Jeugd (IGJ).

The EU MDR defines an incident as “any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.”[17] With ergonomic features, the EU MDR means the physical characteristics of the medical device. In case an error occurred may qualify as an incident, it should be reported to the manufacturer at minimum.