On Tuesday, September 15, 2026, from 9:30 a.m. to 2:00 p.m., we cordially invite you to an exciting workshop with Dr. Katharyn Zetzsche, an expert in Clinical Affairs & Technical Documentation at Metecon GmbH. The topic is: “Regulatory Foundations of Clinical Strategy for Medical Devices.”
Clinical evaluation is a central element in the journey from the product concept to the successful market launch of medical devices. With the MDR, the requirements for clinical evaluation have increased significantly. It ensures that the safety and performance of medical devices are comprehensively demonstrated and thus forms the basis for market access in Europe. In this event, you will gain a practical overview of the current regulatory requirements, typical challenges, and proven strategies for creating and updating clinical evaluations.
This workshop is intended for anyone who would like to learn about the regulatory fundamentals of clinical strategy under the MDR-from clinical evaluation (CE) through clinical trials to post-market clinical follow-up (PMCF).
Here’s what to expect:
| 9:30-9:45 | Introduction and Objectives |
| 9:45-11:00 | Fundamentals of Clinical Evaluation (CE) under the MDR Topics: Role of CE in the technical documentation for MDR approval, Objectives and strategy of CE, required level of evidence, claims, systematic literature searches for state-of-the-art information and product-related data |
| 11:00-11:10 | Coffee break |
| 11:10-12:00 | Clinical Trials Topics: When is a clinical trial necessary, clinical trials under Article 82, study design, submission process, obligations for the investigator/study site |
| 12:00-12:15 | Q&A Session |
| 12:15-12:45 | Lunch Break |
| 12:45-13:45 | Post-market clinical follow-up (PMCF) Topics: Interface between KB and PMCF, general vs. specific PMCF activities, necessity of PMCF studies for clinical follow-up, requirements for the PMCF plan and PMCF report |
| 13:45-14:00 | Q&A and closing remarks |
The workshop will take place in the Weitblick room in the Patientenhaus (UMM,Building 43).
Refreshments will be provided!
Thenumber of participants is limited. Please register by September 11, 2026, via this registration link.
Registration is open to all employees of the M²OLIE Research Campus, the IMT, and the UMM.
We look forward to welcoming you to the workshop on “Clinical Strategy for Medical Devices” and to taking important steps together to translate our research findings into practice!
