Date: 30 October 2025
Time: 16:00 - 17:00 CET | 10 - 11 am EDT
Location: Virtual
Introduction
Join us for an exclusive live webinar, hosted by Qserve in collaboration with TÜV SÜD, on PMCF Activities in Practice. Common Pitfalls and Lessons Learned Through the Eyes of a Notified Body.
Post-Market Clinical Follow-up (PMCF) is a critical requirement under the EU MDR, yet many manufacturers still face challenges in determining what constitutes sufficient data and how to design effective PMCF activities. This webinar brings together the combined perspectives of Qserve experts and TÜV SÜD as a Notified Body, offering a unique opportunity to learn both the practical and regulatory sides of PMCF.
Through case-based discussions and shared experiences, we will highlight common pitfalls, provide practical insights, and give you clear direction on how to strengthen your PMCF strategy. Whether you are new to MDR requirements or looking to refine your existing approach, this session will help you align your PMCF activities with regulatory expectations and avoid costly mistakes.
Agenda
- Welcome and Introduction
- General Introduction to PMCF
- What is Sufficient Data?
- Personal Experiences and Common Pitfalls
- Q&A Session
- Closing Remarks and Resources
Learning Objectives
By the end of this webinar, attendees will be able to:
- Understand the role of PMCF under the MDR and how it differs from the former MDD requirements.
- Understand what qualifies as sufficient PMCF data from the perspective of a Notified Body.
- Recognize common pitfalls in PMCF planning and execution, and learn how to avoid them through real-world examples and practical solutions.
- Apply practical strategies for strengthening PMCF activities to ensure compliance and support the ongoing safety and performance of medical devices.
Presenters
We are excited to have Wouter Mattheussens, Clinical Project Manager at Qserve, as a presenter in our upcoming webinar. With his extensive experience managing clinical studies, expertise in ISO 14155/GCP guidelines, and passion for bringing medical devices to market, Wouter will share practical insights and lessons learned from real-world projects.
We invited guest speaker Dr. Katalin Meszaros, dentist and Clinical Reviewer at TÜV SÜD to join the webinar. With over 18 years of clinical and regulatory experience, I serve as Subject Matter Expert for Dental Devices and also review high risk Annex XVI products such as dermal fillers. My expertise includes clinical evidence assessment, with a focus on evaluating Clinical Evaluation Reports (CERs) and ensuring their effective integration with PMCF activities under the MDR.
Who Should Attend?
This webinar is tailored for professionals working in:
- Regulatory Affairs
- Clinical Affairs
- Post-Market Surveillance
- Quality Assurance
- Medical Writing and Clinical Evaluation
- R&D and Product Development
- RA/QA consultants supporting EU MDR compliance.
Especially relevant for manufacturers of Class II and III devices, or those preparing for MDR submissions or facing PMCF-related non-conformities.