Interested participants from other time zones are welcome to contact us regarding the training at [email protected].
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Post-Market Clinical Follow-up (PMCF) is a cornerstone of the EU Medical Device Regulation (MDR) designed to ensure that clinical evidence remains up to date throughout a product’s lifecycle. It is not a one-time task, but an ongoing, proactive process that verifies the safety and performance of devices once they are placed on the market.
Under MDR, manufacturers must establish and maintain a PMCF plan as part of their Post-Market Surveillance system, ensuring that real-world clinical data continuously supports the benefit–risk profile of the device. This training will provide participants with a comprehensive understanding of both regulatory requirements and practical approaches to implementing PMCF effectively.
Key Topics Covered
Regulatory Framework and Guidance
- MDR 2017/745 requirements (Articles 61, 83–86, Annex XIV Part B)
- MDCG guidance documents (e.g., MDCG 2020-7, MDCG 2020-8, MDCG 2021-6)
- Relationship between Clinical Evaluation, PMS and PMCF
- Expectations from Notified Bodies and Competent Authorities
Developing a PMCF Plan
- Structure and content of a compliant PMCF plan
- Defining objectives, rationale, and scope
- Selection of appropriate PMCF methods (surveys, registries, literature reviews, clinical investigations, etc.)
- Integration with the Clinical Evaluation Plan and PMS Plan
Executing PMCF Activities
- Data sources and collection methodologies
- Risk-based approaches to PMCF design
- Managing data quality and completeness
- Examples of proportional PMCF for low-risk and high-risk devices
Analyzing and Reporting PMCF Data
- Structuring PMCF Evaluation Reports
- Linking PMCF outcomes to Clinical Evaluation Reports and Risk Management Files
- Closing the feedback loop into PMS and technical documentation
- Documentation expectations during audits and technical file reviews
Practical Application and Case Studies
- Review of real-world PMCF strategies and notified body feedback
- Lessons learned from audit findings and (EU) MDR conformity assessments
- Digital tools and systems to manage PMCF data
Best Practices and Continuous Improvement
- How to maintain a living PMCF process
- Periodic updates and alignment with new clinical evidence
- Effective cross-functional collaboration between clinical, regulatory, and quality teams
Benefits of this Training
- Gain clarity on regulatory expectations and Notified Body scrutiny of PMCF
- Learn how to design, execute, and document effective PMCF activities
- Acquire practical strategies to align PMCF with PMS and CER requirements
- Increase confidence in audit readiness by understanding best practices
- Strengthen ability to generate meaningful clinical evidence that supports safety, performance, and compliance.
By the end of this session, participants will have the knowledge and practical insight to move beyond theory and ensure PMCF is not just a regulatory requirement, but a strategic tool for continuous compliance, product safety, and clinical excellence.
Target Audience: Regulatory Affairs specialists/Managers, Clinical Affairs Managers, R&D teams, Quality Assurance Managers.
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under (EU) MDR.
Auditors
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Irenej Polacek
Moderator
Technica file reviewer / Auditor
A graduate biomedical engineer specialising in prosthetics, orthotics, orthopaedics, and custom-made cranio-maxillo-facial implants, he worked at CEIT Biomedical Engineering during his PhD. He gained extensive experience in dental medical devices as a product specialist at FONA Dental, collaborating with the design team and end users. He then joined 3EC International, a Slovak notified body, where he spent four years as a technical file reviewer and lead auditor, completing training in MDR, risk management, usability, PMS, and external auditing. Later, at DQS, he earned certifications from their comprehensive MDR, ISO 13485, and MDSAP conformity assessment training.