REGULATORY AFFAIRS under MDR
The usability engineering process is an important foundation in the development of safe and usable medical devices. The European Medical Device Regulation (MDR) 2017/745 includes numerous requirements with regard to the usability and ergonomics of medical devices to reduce risks due to application errors by patients, users and third parties. Medical devices developed without applying a usability-oriented development process can lead to user-product interfaces (user interfaces) that are difficult to apply and thus to user errors. Through the systematic use of usability engineering, potential hazards that may arise during the use of the medical device can be uncovered and the likelihood of application errors can be reduced or prevented through appropriate adaptation of the user-product interface (user interfaces).
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suitability for use
Manufacturers of medical devices are therefore obliged to take usability into account duringthe development process and to develop and produce their products in such a way that their use does not endanger the health and safety of patients, users or, where applicable, third parties. The information provided by the manufacturer must also be easy to understand and apply.
Some of the requirements of the MDR for manufacturers in terms of usability and ergonomics of medical devices are, for example:
Usability Engineering Process
The usability engineering process must not only cover the normal operation of the device, but also take into account transportation, storage, installation, maintenance, repair and disposal. In addition, after the medical device has been placed on the market, feedback from users and information about problems should be collected and evaluated in Post-Market Clinical Follow-Up (PMCF) and Post-Market Surveillance (PMS) in order to adapt and improve the usability of the product and safety information (e.g. warnings, operating instructions) if necessary.
The basis of usability engineering for medical devices is the IEC 62366-1 standard “Application of usability to medical devices”. IEC 62366-1 defines usability as “the property of the user-product interface that includes effectiveness, efficiency, ease of learning, and satisfaction of the user.” user.” IEC 62366-1 includes all the requirements for a usability-oriented medical device development process to develop user-friendly, safe, and ergonomic medical devices. The risks identified by the usability engineering with the use of the medical device are further analyzed, evaluated and controlled in the risk management according to ISO 14971. Usability engineering is therefore closely intertwined with risk management; together, the two processes ensure safe and effective medical devices. The process of usability engineering is documented in the usability engineering file.
We support you in implementing the requirements of the MDR and help you to create an IEC 62366-1 compliant usability engineering file.