Module 14: Design Development and Certification of Medical Devices

What are the current Human Factors and Usability Engineering regulations?

The European Medical Device Regulation (2017/45/EC)

Compliance to the Performance Requirements stated in Annex I are the basis for CE Marking a medical device if this is the regulatory route chosen. The ones related to human factors and usability are specific and are:

Not limited to, but include Sections - 1, 3(b), 3(c), 4(c), 5(a), 5(b), 8, 10.2, 11.1, 11.2, 14.2(a), 14.4, 14.6, 14.7, 18.4, 22.1 & 22.2. The terms ergonomics, usability, safe use or human factors are frequently stated in the new MDR!

The Organisation for Professionals in Regulatory Affairs

Assessing Usability and Performance during development