Usability and validation from a single source

An investigation of the incidents reported to the BfArM showed that 42.1 percent of the incidents were caused by the usability of medical devices. International studies have also shown that many incidents involving medical devices were caused by misuse of the device. The usability of medical devices is there-fore increasingly in the interest of the public and legislators.

Usability as a Regulatory Requirement
Due to this negative development, requirements for usability-oriented development were added to the Essential Requirements in Annex I of Directive 93/42/EEC by means of the European Directive 2007/47/EC. The new Regulation on Medical Devices (EU) 2017/745 and the Regulation on In-Vitro Diagnostics (EU) 2017/746 also contain numerous basic safety and performance requirements regarding the usability of products.

Every manufacturer of medical devices has been obliged to assess the usability in the development process and to adapt and design the devices specifically to the needs of the intended users.

Normative Requirements for the Usability of Medical Devices
Usability and ergonomics have become important quality and performance features of medical devices. The two standards EN 62366-1 and EN 60601-1-6 are harmonized under the Medical Device Directive (93/42/EEC and 98/79/EC) and describe how the usability requirements are to be considered in the development process of medical devices. For this purpose, a process is required for carrying out usability engineering as well as the documentation of the results within a usability file. Here, too, the safety concept of the legislator is decisive. The application errors in the use of a product are to be identified, processed and, if necessary, addressed as a decisive element. For this purpose, these considerations are documented in a structured manner and treated based on defined transfer points either in the risk management of the manufacturer and/or the clinical evaluation of the manufacturer. The usability of a product should also be tested and confirmed by means of formative or summative tests.

In addition, manufacturers must also consider international requirements, as the products are usually sold in several markets. Here it is also important to comprehensively identify the product specifications in development planning based on the applicable regulations.

Interfaces to Other Processes
Both in the harmonized standards and in practice, there are numerous interfaces between the processes of usability, risk management and clinical evaluation. The responsible and involved employees must know these interfaces in order to guarantee an efficient process flow, to prevent inconsistencies within the technical documentation and to avoid redundancy. The planning of chronological processes and dependencies have a great influence on the development result and the approval of your medical device.

How We Can Help
Use our expert knowledge already in the idea phase and feasibility analysis. This is where the ergonomics and usability process begin, not the finished product. The consideration of the users and the integration of the customers into the development are the key to success.

NSF International offers you the necessary expertise to implement the usability requirements and works with you to develop plans and specifications for the validation of your medical devices.

NSF International (former PROSYSTEM) is a member of the working group IEC 62A/ISO 210 JWG4 and works on the standards IEC 62366-1 and IEC 62366-2. Use our network for your future development projects and benefit from our first-hand information.

NSF International has experts with many years of practical experience who can implement the optimal processes for you. Let one of our independent auditors evaluate and improve your internal processes, interfaces and procedures.

Please contact us for further details on“Usability and Validation” or a non-binding offer. Take the opportunity to attend one of our seminars.