Under the EU Medical Device Regulation (MDR 2017/745), Post-Market Surveillance and Vigilance are no longer optional but legal obligations central to a device's lifecycle. Manufacturers must establish a proactive, systematic PMS plan and maintain a Post-Market Clinical Follow-up (PMCF) where applicable, ensuring continuous evaluation of safety and performance. Vigilance requirements demand timely incident reporting, trend analysis, and corrective actions, all closely monitored by Competent Authorities.
The EU has a structured approach to PMS, as outlined in the Medical Device Regulation. Manufacturers are required to establish a comprehensive PMS system that includes a PMS Plan — a documented strategy for monitoring device performance and safety — a Post-Market Surveillance Report to summarize PMS findings (updated regularly), and, for higher-risk devices, a Periodic Safety Update Report (PSUR) summarizing PMS results and any corrective actions taken.
This training provides practical guidance on implementing compliant PMS and Vigilance systems, from preparing robust PSURs and PMCF reports to navigating EUDAMED (European Database on Medical Devices) reporting requirements. Participants will learn how to transform regulatory obligations into opportunities — strengthening product safety, achieving MDR compliance, and driving long-term market success.
Content Overview
- Post-Market Surveillance vs. Post-Market Clinical Follow-up
- Vigilance & Incident Management under (EU) MDR
- Transition from MDD to MDR: Key changes
- Integrating PMS and Vigilance into the QMS
- Practical Implementation
- Audits & Compliance
- Value of PMS & Vigilance
- Case studies, group exercises, and Q&A sessions
Benefit
This course offers more than regulatory interpretation. It empowers your organization to proactively monitor product safety, reduce regulatory risk, and streamline vigilance reporting. Learn directly from regulatory experts and auditors with first-hand experience in MDR compliance.
Target Audience
This training is designed for professionals involved in the lifecycle management, regulatory compliance, and safety of medical devices, including:
- Regulatory Affairs Managers
- Quality Assurance Teams
- Research & Development Specialists
- Clinical Affairs Specialists
Certificate
Participants receive a Certificate of Attendance of DQS MED GmbH
Frequently asked questions
Do I need prior MDR certification to join?
No formal certification is required. The course is most valuable for professionals already working in regulatory, quality, or clinical roles who want practical, applicable guidance on PMS and Vigilance.
Do legacy devices certified under the old MDD still need PMS and Vigilance activities?
Yes. Devices that remain on the market under a Medical Device Directive (MDD) certificate during the transition period are still subject to MDR's Post-Market Surveillance and Vigilance obligations, including PSUR and incident-reporting requirements where applicable to their risk class.
How often does a PSUR need to be updated?
Under Article 86 of (EU) MDR, the update frequency depends on device classification: Class IIa devices require a PSUR at least every two years, while Class IIb and Class III devices require one at least annually.
What are the reporting deadlines for a serious incident?
Under Article 87 of (EU) MDR, timelines depend on severity: serious public health threats must be reported within 2 days, deaths or unanticipated serious deteriorations in health within 10 days, and other serious incidents within 15 days — all counted from when the manufacturer becomes aware.
Interested participants from other time zones are welcome to contact us regarding the training at [email protected]
Auditors
Christiane Dr. Reinwald
