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


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

This webinar was recorded on May 20, 2021.

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