The EU MDR and Human Factors Engineering (HFE) Requirements for Post-Market Surveillance (PMS)

The EU Medical Devices Regulation (MDR) includes specific requirements for post-market surveillance (PMS), calling on medical device manufacturers to provide a detailed PMS plan in their submission. PMS has often been overlooked in the past, and it has never been subject to a requirement relating to human factors engineering (HFE). Current HFE standards (such as IEC 62366-1) do not even provide guidance on the subject of PMS, which is a fair indication of the relationship between PMS and HFE to date.

When given some thought, it becomes clear that new post-market HFE processes will need to be devised because such activities have not previously been mandatory. In this webinar, the presenters will help attendees develop a greater understanding of the EU MDR’s post-market surveillance HFE requirements, and they will draw up a roadmap to compliance (or an "HFE PMS plan"). Specifically, the presenters will discuss various passive and active PMS activities and outline a systemic process that empowers HFE practitioners to contribute to developing a PMS plan for gathering HFE-related data proactively after product launch.

The webinar’s goal is to provide attendees with sufficient content to enable them to:

• Initiate a necessary dialogue in the industry surrounding HFE PMS activities and requirements
• Understand the EU MDR’s post-market surveillance HFE requirements and the implications for HFE practitioners
• Understand how to determine the appropriate level of passive and active PMS for a given development effort, based on factors such as intended users and context of use
• Develop a scalable plan for (1) generating valuable passive data and deciding how and when to effectively act on it, and (2) pro-actively gathering HFE data after product launch
• Employ effective methods for deriving and analyzing HFE data obtained from conducting PMS activities

PRESENTERS:

Yvonne Limpens, Managing Human Factors Specialist
Natalie Shortt, Managing Human Factors Specialist

This webinar was recorded on May 20, 2021.