Overview
This compact 90-minute course provides a focused introduction to Post-Market Surveillance (PMS) requirements under EU MDR 2017/745 and U.S. Section 522 FD&C Act. Participants will learn how to structure compliant PMS plans and reports, understand the role of PMCF and PSURs, and identify key differences between EU and U.S. obligations. The course also introduces relevant standards such as ISO 13485:2016 and ISO/TR 20416, helping manufacturers align global processes and avoid regulatory pitfalls. Ideal for quality, regulatory, and clinical professionals seeking efficient compliance strategies in both jurisdictions medical software on the market in Europe
Topics include:
- Key PMS obligations under EU MDR (Articles 83–86)
- Structure and content of PMS Plan, PMS Report, and PSUR
- U.S. FDA’s Section 522 post market surveillance studies
- Integration of ISO 13485:2016 and ISO/TR 20416 into PMS
- Comparison of timelines, triggers, and enforcement mechanisms
- Best practices for globally aligned PMS processes
- The course is ideal for regulatory, quality, and clinical teams seeking to ensure compliance and efficiency across both regulatory landscapes.
Why Should You Attend
- Mandatory knowledge for manufacturers Post-Market Surveillance (PMS) is not a “can do”, but a key regulatory must. Those who do not set up PMS processes in a compliant manner risk complaints from Notified Bodies (EU) or the FDA (USA).
- Compact overview - internationally relevant In just 90 minutes, you will gain a sound overview of the requirements of both markets - EU and USA - and systematically learn about the differences and similarities.
- Avoiding typical errors and risks Missing or incorrect PMS documents are among the most common reasons for negative audit or inspection results. The course shows you how to set up your documentation and processes correctly.
- Combining standards and practice You will learn how to embed ISO 13485:2016 and ISO/TR 20416:2020 in PMS systems in a meaningful way - including tips for implementation in practice.
- Competitive advantage through regulatory sovereignty Manufacturers who take PMS seriously and live it transparently strengthen their market approval, reputation and product safety in the long term.
- Ideal for international teams If you operate in several markets, you have to deal with different regulatory expectations. This course facilitates the harmonization of internal processes.
Webinar Takeaway
Introduction to Post-Market Surveillance (PMS)
- Importance and objectives of PMS in the regulatory context
- Differentiation from vigilance and PMCF
PMS according to EU MDR 2017/745
- Legal basis: Articles 83-86 MDR
- Requirements for:
- PMS plan
- PMS report (for class I)
- Periodic Safety Update Report (PSUR - classes IIa, IIb, III)
- Post-Market Clinical Follow-up (PMCF)
- Integration into the quality management system in accordance with ISO 13485:2016
- Implementation instructions according to ISO/TR 20416:2020
PMS according to U.S. FDA - Section 522 FD&C Act
- Legal framework:
- 21 CFR Part 822 - Postmarket Surveillance
- 21 CFR Part 803 - Medical Device Reporting (MDR system)
- When and how does the FDA require PMS studies?
- Role of MedWatch, MAUDE database and PMA/510(k) follow-up
Comparison EU vs. USA
- Similarities and differences in:
- Reporting obligations and deadlines
- Study design and clinical data requirements
- Roles and responsibilities
- Typical challenges in international harmonization
Best practices and implementation aids
- Recommendations for the creation of PMS plans
- Tips for audits and FDA inspections
- Lessons learned from practice and feedback from authorities
Q&A / discussion
- Room for questions and exchange of experiences
Who Will Benefit
- Regulatory Affairs Managers
- Quality managers and QMS officers
- Specialists for post-market surveillance (PMS) and vigilance
- Manufacturers, distributors and authorized representatives
- Clinical evaluations & PMCF officers
- Professionals coordinating EU and US market requirements
Description
This compact 90-minute course provides a focused introduction to Post-Market Surveillance (PMS) requirements under EU MDR 2017/745 and U.S. Section 522 FD&C Act. Participants will learn how to structure compliant PMS plans and reports, understand the role of PMCF and PSURs, and identify key differences between EU and U.S. obligations. The course also introduces relevant standards such as ISO 13485:2016 and ISO/TR 20416, helping manufacturers align global processes and avoid regulatory pitfalls. Ideal for quality, regulatory, and clinical professionals seeking efficient compliance strategies in both jurisdictions medical software on the market in Europe
Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
