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Post-market Human Factors Engineering Requirements. A roadmap to comply with European Union Medical Devices Regulations’ post-market surveillance expectations
Event Type
Oral Presentations
TimeThursday, April 1512:50pm - 1:10pm EDT
LocationMedical and Drug Delivery Devices
DescriptionImminently, manufacturers that want to submit their products to the European market will be expected to have a post market surveillance (PMS) plan in place for their product’s lifecycle. While the (soon to be repealed) Medical Device Directive (MDD) essentially served as a manual for how medical device manufacturers could obtain CE marking to market their medical devices in the European Union (EU), the Medical Device Regulation (MDR) requires policies and procedures that elevate the responsibilities of medical device manufacturers for their devices throughout the product lifecycle, including post-market surveillance (PMS).

One of the drivers that sparked the development of the EU MDR to create a process where regulation focusses on the entire product lifecycle as opposed to only product pre-approval, is the aging population. The aging population independently using medical devices face greater risks associated with medical device malfunctions and adverse events than younger users.

Unlike the MDD, the MDR expects manufacturers to include use-related risk management in their PMS plans. The MDR includes specific PMS requirements calling on medical device manufacturers to proactively develop a PMS plan, and conduct passive and active PMS activities. PMS has often been overlooked, and PMS as it relates to HFE has never been a requirement in the past – HFE standards (such as IEC62366-1) provide no/minimal 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 been mandatory to date.

During this talk, the presenters will help develop a greater understanding of the EU MDR’s post-market surveillance HFE requirements, and provide a roadmap to compliance. Specifically, the presenters would like to initiate a necessary dialogue in industry regarding what role HFE could or should play in PMS, as well as share information and considerations from an HFE perspective that will help HFE practitioners to provide input to a PMS plan to meet the MDR PMS requirements.
Authors
Managing Human Factors Specialist
Senior Human Factors Specialist