Introduzione
PMCF under MDR: Turning Compliance into Clinical Value
Post-Market Clinical Follow-up (PMCF) is a critical element of Post-Market Surveillance (PMS) under the EU Medical Device Regulation (MDR). While the requirements are well known, defining an effective PMCF strategy that truly supports the clinical evaluation and long-term safety of a device remains a challenge.
This course provides a clear and practical overview of PMCF requirements under the MDR, helping participants navigate the selection of suitable PMCF activities based on device classification, available evidence, and market history.
Through concrete examples and guided discussions, you will learn how to plan, structure, and document your PMCF activities effectively — from the initial strategy to the final evaluation report — avoiding common pitfalls and building clinical evidence that stands up to regulatory scrutiny.
Programme
- Purpose of PMCF
- Requirements under MDR (MDR ANNEX XIV Part B)
- Types of PMCF activities
- PMCF Plan and Report: Structure/Content
Medical Writers, Quality Assurance, Product Managers, Regulatory Affairs.
Participant experience
This workshop is intended for people with limited experience in PMCF under MDR.
Presentation, team discussions, practical examples.
Docente/i
Geneviève Laumen
Geneviève Laumen is a freelance Medical Writer specializing in clinical evaluation documentation for medical devices in compliance with European regulatory requirements.
She supports manufacturers in preparing Clinical Evaluation Plans and Reports, State of the Art reviews, and Summary of Safety and Clinical Performance (SSCP) documents across a wide range of device classes and therapeutic areas.
Before starting her freelance activity, Geneviève worked within the medical device industry as a Clinical Evaluation Manager, gaining hands-on experience in regulatory compliance and clinical evidence generation under the MDR framework.
She is based in Oldenburg, Germany, and collaborates with international clients to ensure high-quality, consistent, and compliant clinical evaluation deliverables.
Online Training – 1 module
07 April 2027 from 2:00 pm to 6:00 pm CEST
Few days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 490,00* (until 17/03/2027)
Ordinary: € 620,00*
Freelance – Individual – Academy – Public Administration: € 410,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Ilaria Butta
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
