Post-market Surveillance and Vigilance under the MDR and IVDR EN

BSI’s Post-Market Surveillance (PMS) and Vigilance under the MDR and IVDR is a focused one-day course designed for medical device and IVD manufacturers. The training equips you with practical tools to establish and maintain an effective system for collecting, reviewing, and acting on post-production feedback across your device portfolio—supporting regulatory compliance and continual improvement.

By the end of the training, you will be able to: • Interpret the PMS and vigilance requirements under the EU MDR and IVDR • Map these requirements to ISO 13485:2016, ISO 14971:2019, and key EU/IMDRF (GHTF) guidance documents • Create a risk-driven Post-Market Surveillance Plan that integrates proactive and reactive data sources • Implement appropriate PMCF (under MDR) and PMPF (under IVDR) activities • Recognize and escalate incidents and adverse events that require reporting to Competent Authorities and Notified Bodies for both pre- and post-CE-marked devices