Post-Marketing Surveillance according to MDR regulation
Dates TBD

Post-Marketing Surveillance (PMS) according to MDR regulation: key points and challenges

English | 
Stay ahead in medical device safety: Master the MDR’s PMS requirements to excel in market surveillance and patient care.

In January 2022, the European regulation on medical devices (MDR) introduced changes in the requirements for post-marketing surveillance (PMS). This course will review the key points and challenges related to post-marketing surveillance under MDR.

  • New PMS Requirements MDR places greater emphasis on post-marketing surveillance, requiring manufacturers to establish a robust PMS system. This course will evaluate effective methods for manufacturers to collect, record and analyze relevant data on the quality, performance, and safety of their devices actively and systematically.
  • Periodic Safety Update Reports (PSUR) Manufacturers must submit periodic safety update reports for Class IIa, IIb and III devices. This course will detail all the information that a PSUR must include for the correct analysis of the data and the evaluation of the benefit-risk balance.
  • Trend Reports MDR includes the need for trend reports. Manufacturers must proactively identify and report trends that may indicate possible safety or performance issues. This course will evaluate and present effective procedures for trend analysis.
  • Post-Marketing Clinical Follow-up (PMCF) MDR introduces stricter requirements for post-marketing clinical follow-up, including the need for a PMCF plan for certain devices. This course will evaluate everything a PMCF study must include to collect additional clinical data during the post-marketing phase.
  • Data Collection and Analysis This section will present strategies to ensure that the collected data is complete, accurate and relevant to the safety of medical devices. Strategies will also be presented to ensure compliance with established deadlines.
  • Adapting to the New Requirements The transition to the new MDR requirements and how medical device manufacturers can adapt their existing systems and processes to comply with the current regulation will be evaluated.

Managers and technicians from Medical Device Surveillance departments and professionals from medical device manufacturing companies.

Laura Eder
Drug Safety Associate Director

PhD in Biomedical Research, as well as a background in Biology and Biochemistry and a Master’s degree in Health Administration.

Solid experience in Pharmacovigilance audits, Medical Writing and in overall Pharmacovigilance activities.

The course is delivered in one 4-hour session from 2 p.m. to 6 p.m.

Price: 400€

Early Bird: 10% discount up to 30 days before training date.

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