Navigating Post Market Surveillance Requirements in International Waters and in a Changing Regulatory

Regulators are heightening post market surveillance requirements to ensure medical device safety issues are identified as early as possible, therefore minimizing the risk of impact on patient and user safety. Regulatory Bodies are implementing stringent requirements for more proactive post market surveillance mechanisms, instead of relying on current reactive systems, such as complaints monitoring.

In the EU, specifically, it is crucial for manufacturers to review their systems, processes, and procedures for post market surveillance to ensure that they are compliant not only with the increasingly demanding requirements expected in the new Medical Device Regulation, but also with those of the single countries they distribute to.

This must-read guide outlines current regulatory requirements globally and explains how manufacturers worldwide can achieve post market surveillance compliance.  In particular, the guide looks at:

  • The global climate that has led to increasing scrutiny on post market surveillance by Global Regulatory Bodies
  • How manufacturers can successfully review post market surveillance systems, processes, and procedures in time for the next Regulatory Body Audit or review
  • The varying post market surveillance requirements in different geographies
  • The expectations of different regulating bodies
  • Challenges facing manufacturers
  • Practical examples of dealing with challenges
  • The role of personnel training in investigations and vigilance reporting