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I’ve never had to do usability before – so why do I have to now?

I’ve never had to do usability before – so why do I have to now?

The MDR aims (among other things) to guarantee safe and innovative medical devices. In order to ensure safe use, some requirements are placed on the usability of your product. These can be found mainly in the “General Safety and Performance Requirements” (Annex 1 of the MDR). Since Annex 1 applies to all medical devices, you are obliged to address usability for compliance with the requirements made there.

Deep Dive: MDR and Usability

Deep Dive: MDR and Usability

The MDR makes demands on the Usability of your medical device, but leaves it open how you fulfill them. There are no regulations on this. However, there is a list of harmonized standards that can greatly facilitate implementation. This includes the Usability Engineering process according to IEC 62366-1.