Regulation (EU) 2017/745 on medical devices (MDR) requires manufacturers to fulfill much more specific obligations with regards to usability.
It is important to note that these requirements are applicable for all types of medical devices.
For example, annex I (3) requires the manufacturer to have a risk management system in place that “estimate[s] and evaluate[s] the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;”
Annex I (5) then requires manufacturers to reduce risks related to use error by
“a) reduc[ing] as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
(b) giv[ing] consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).”
There are more aspects that should be considered in this context. As such, manufacturers must also include usability considerations in their PMS activities.
Please follow IEC 62366-1
The bottom line is to make use of available standards. Although no standards have been harmonized yet under the MDR, manufacturers are best advised to follow IEC 62366-1 because this represents the current state-of-the-art.
As always, should you have any questions or concerns, please don’t hesitate to get in touch!