Legacy Devices Under EU MDR: 3 Real-World Challenges Manufacturers Solved – A Customer Perspective
Overview
Where
Online Webinar
When
10:00 AM – 11:00 AM ET
Webinar Overview
Post-Market Clinical Follow-up (PMCF) under EU MDR has become one of the most closely evaluated areas in regulatory submissions. While expectations are clearly defined in Annex XIV, applying them in a practical, scalable way continues to be a challenge for many medical device manufacturers.
Organizations often face uncertainty when selecting the right PMCF approach, managing limited clinical data, and responding to Notified Body feedback. What appears sufficient during planning frequently requires further justification, additional data collection, or refinement during review cycles.
In this webinar, regulatory leaders and medical device manufacturers will share a practical customer perspective on how PMCF is being implemented today. Rather than focusing on theory, the discussion will highlight real-world experiences across different device types, including how teams approached PMCF planning, addressed data gaps, and adapted strategies based on regulatory feedback.
The session will focus on key areas that manufacturers are actively working through:
- Defining a proportionate and defensible PMCF strategy
- Selecting appropriate data collection methods such as real-world evidence, surveys, and studies
- Addressing Notified Body observations on PMCF plans and reports
- Managing cost, timelines, and internal resources while maintaining compliance
Attendees will gain a clearer understanding of how PMCF challenges appear in real projects and how different organizations are approaching them in practice.
Learning Objectives
By attending this webinar, participants will learn:
- The key challenges manufacturers face when implementing PMCF under EU MDR, including gaps in clinical data and evolving regulatory expectations
- How to select appropriate PMCF methods based on device class, lifecycle stage, and available evidence
- Common Notified Body observations on PMCF documentation and how to address them proactively
- Practical approaches to optimize PMCF activities while managing cost and operational effort
- Lessons learned from real-world PMCF implementations across legacy devices, novel technologies, and recertification scenarios
Discussion Points
Challenge 1: Defining the Right PMCF Strategy
Manufacturers often struggle to determine what level of PMCF is appropriate for their device. While PMCF is expected under MDR, the approach can vary significantly depending on device risk, available clinical data, and prior market history.
This discussion will explore how organizations are defining proportionate PMCF strategies and aligning them with regulatory expectations.
Challenge 2: Selecting the Right Data Collection Approach
PMCF can be conducted through multiple methods, including literature reviews, real-world evidence, registries, surveys, and clinical investigations. Choosing the right approach requires balancing scientific validity, feasibility, and cost.
The panel will discuss how manufacturers are selecting and justifying data collection methods, including when survey-based approaches or real-world data are appropriate.
Challenge 3: Addressing Notified Body Feedback
Notified Body observations on PMCF plans and reports often highlight gaps in methodology, endpoints, or justification. These can lead to delays if not addressed effectively.
This discussion will focus on common feedback themes and how manufacturers are strengthening their PMCF documentation to meet expectations.
Challenge 4: Managing Cost and Operational Complexity
PMCF activities can become resource-intensive, particularly for large device portfolios. Teams must balance regulatory expectations with internal capacity, timelines, and cost considerations.
The panel will share practical approaches to improving efficiency while maintaining compliance, including the use of existing data sources and targeted study designs.
Who Should Attend
This webinar is designed for professionals involved in EU MDR compliance and post-market activities for medical devices, including:
- Regulatory Affairs Leaders
- Clinical Evaluation Specialists
- Medical Writers working on CERs and PMCF documentation
- Quality and Compliance Leaders
- PMS / PMCF Program Managers
- Clinical Affairs and Evidence Generation Teams
It is particularly relevant for organizations managing PMCF programs across legacy devices, new product introductions, or MDR recertification efforts.
Why Attend
Participants will gain insights from real-world PMCF challenges experienced by manufacturers, including how teams addressed data gaps, selected appropriate methodologies, and responded to regulatory feedback.
The session provides practical takeaways that can be applied when planning PMCF activities, preparing documentation, or engaging with Notified Bodies.
Webinar Speakers
Medical & Clinical Strategy Advisor
Julie Jakubowski, MD, FACP
Julie Jakubowski is an Internal Medicine physician-executive with extensive experience in Medical Affairs and Clinical Development across pharmaceuticals, medical devices, and diagnostics. She spent over 13 years at Baxter International, where she led medical strategy across a $1B portfolio, supporting evidence generation, regulatory strategy, and product lifecycle management. Julie has also served as Assistant Professor of Medicine at Northwestern Memorial Hospital and has published in areas including metabolic disease, nutrition, and digital medicine.
Director, Regulatory Affairs, Acumed
Aram Tran
Aram Tran is a regulatory affairs leader with 14 years of experience in orthopedic medical devices, spanning manufacturing, R&D, product management, and quality assurance. He currently leads Regulatory Affairs at Acumed, driving regulatory excellence and continuous improvement across functions including post-market surveillance, clinical affairs, sustaining, and new product introduction. His cross-functional expertise enables alignment between development, compliance, and business strategy.
Vice President of Global Regulatory Affairs and Quality, Argon Medical Devices
Scott Bishop, MS
Scott Bishop leads global regulatory strategy and quality oversight at Argon Medical Devices. He brings extensive experience in EU MDR transitions, including technical documentation alignment, notified body engagement, post-market surveillance integration, and quality system readiness. Known for his risk-based approach, he aligns regulatory and quality strategy with business goals while maintaining compliance across global markets.
Webinar Moderator
Senior SME, Medical Device Services, Celegence
Priya Ray Chaudhuri
Priya Ray Chaudhuri is a life sciences professional with over 11 years of experience specializing in regulatory medical writing and clinical evaluation for medical devices. She has strong expertise in EU MDR documentation, including CEPs, CERs, and PMS/PMCF activities. At Celegence, she leads a team supporting clinical evaluation strategy, evidence generation, and responses to Notified Body reviews.
Where
Online Webinar
When
10:00 AM – 11:00 AM ET
Share
Other Related Articles
12 Mar, 2026
27 May, 2025
