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Post-Market Surveillance, PSUR and Vigilance under MDR and IVDR Course & Certification
Intermediate
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Post-Market Surveillance, PSUR and Vigilance under MDR and IVDR
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About
Post-Market Surveillance, PSUR and Vigilance under MDR and IVDR provides a practical overview of the regulatory requirements for monitoring medical device safety and performance after market placement. It helps learners understand PMS systems, post-market data analysis, PSUR preparation and updates, serious incident reporting, trend reporting, and Field Safety Corrective Actions (FSCAs).
This course covers key requirements under EU MDR 2017/745 and IVDR 2017/746, including PMS planning, benefit-risk evaluation, Field Safety Notices (FSNs), vigilance reporting, and the relationship between post-market monitoring and risk management. Upon successful completion, learners will gain practical knowledge to support regulatory compliance, strengthen vigilance processes, maintain audit readiness, and promote the continued safety and performance of medical devices and in vitro diagnostic medical devices.
Who Should Enrol?
- Medical Device Regulatory Affairs Professionals
- Quality Assurance and Quality Management Professionals
- Post-Market Surveillance and Vigilance Specialists
- Regulatory Compliance Professionals
- Medical Device and IVD Manufacturers
- Professionals Responsible for PMS Reports and PSURs
- Risk Management and Clinical or Performance Evaluation Professionals
- Anyone involved in post-market monitoring, incident reporting, and EU MDR or IVDR compliance
What you will learn
Understand the fundamentals of Post-Market Surveillance (PMS), including its purpose, regulatory requirements, PMS planning, data collection, and safety and performance monitoring under EU MDR and IVDR.
Learn the key requirements for Periodic Safety Update Reports (PSURs), including report preparation, update frequencies, benefit-risk evaluation, and the analysis of post-market safety and performance data.
Develop practical knowledge of vigilance requirements, including serious incident reporting, trend reporting, Field Safety Corrective Actions (FSCAs), Field Safety Notices (FSNs), and applicable reporting timelines.
Understand how PMS, PSUR, and Vigilance activities support regulatory compliance, risk management, corrective and preventive actions, and the continued safety and performance of medical devices and in vitro diagnostic devices.
Course Syllabus
- A system, not a procedure
- Eight limbs, and the collection exists to serve them
- The sentence that closes paragraph three
- The plan, and the annex that says what is in it
- The numbers that make the plan enforceable
- The IVDR is its own regime, and the numbers prove it
- What is law today, what is due, and what is only proposed
- The definitions that decide everything
- Seriousness, causality, and harm the device never touched
- Awareness starts the clock
- Three deadlines, and the paragraph that governs them
- Doubt, incompleteness, and an exemption with a condition
- Field safety corrective actions, and notices that arrive
- The form, the terminology, the guidance and the evidence
- Four duties, and three of them are already due
- What Article 88 actually catches, limb by limb
- Why nothing prompts you, and it is structural
- The carve-out trap, and Module 2 planted it
- What a defensible methodology actually looks like
- The guidance, the draft nobody published, and the IVDR
- Article 85, and the report that is not a small periodic report
- Article 86, and the three things the class I report need not carry
- The FREQUENCY cut line, taught on its own terms
- The ROUTING cut line, and it is a different line
- Crossing the two lines, on four devices and on one report
- The IVDR is its own regime, and the numbers are not analogies
- The guidance, the channel that is not open, and the proposal
- Part 4A is adopted law, and it has been for over a year
- The deadlines match exactly. Five differences survive
- Regulation 44ZN, and why it is wider than Article 88
- The Great Britain periodic safety update report
- The channel: one portal, two form families, two clocks
- Northern Ireland, and three regimes running in parallel
- Enforcement, currency, and the finished half
- Article 88 restated, because the course is named for it
- One question per module, and its answer in a sentence
- Failure One to Five
- Readiness Checks One to Three
- What is expected to move, and what is stable underneath it
- What this course deliberately did not do, and why not
- Five Things to Take From This Course
- 📘 Bonus: PMS, PSUR & Vigilance under MDR and IVDR eBook (Free with purchase)
Course Benefits
eBook
Access the course content in eBook format, which can be downloaded and read on your device.
CPD Points
Earn CPD Points to support your professional development in Post-Market Surveillance, PSUR, and Vigilance under EU MDR and IVDR, subject to applicable eligibility criteria.
Certification
Receive a personal certificate upon course completion to demonstrate your knowledge of Post-Market Surveillance, PSUR, and Vigilance under EU MDR and IVDR.
Affordable
Get excellent value with cost-effective pricing, plus group discounts for larger purchases.
Flexibility
Learn at your own pace with convenient online access, allowing you to complete the course anytime, anywhere.
Keep Up to Date
Stay informed about the latest PMS, PSUR, and Vigilance requirements, regulatory guidance, and updates under EU MDR and IVDR through regularly reviewed course content.
Learn from Industry Experts
Learn from medical-device regulatory, quality, and compliance professionals through practical insights into PMS, PSUR, and Vigilance requirements under EU MDR and IVDR.
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