Introduzione
The requirements for Post-Market Clinical Follow-up (PMCF) as part of Post-Market Surveillance (PMS) under the MDR are well-known and most medical device manufacturers have robust procedures in place.
However, selecting the right PMCF activity for a medical device, considering the available clinical evidence, device classification and market history, remains a challenge. User surveys are often associated with low response rates, PMCF studies are sometimes conducted with inappropriate endpoints, and registries might provide incomplete information.
Therefore, it is crucial to identify the most suitable PMCF method right away to save time and costs.
The workshop will briefly review the PMCF requirements under the EU MDR 2017/745 and will then dive into different methods to collect clinical data in the post-market phase.
This includes user surveys, different designs for PMCF studies, registries, or electronic health records.
Participants will have the chance to work on several case studies to learn how to select the ideal PMCF activity for medical devices with different requirements regarding the expected clinical evidence.
- Short introduction to Annex XIV Part B of EU MDR 2017/745 (Post-Market Clinical Follow-up)
- User surveys:
- Best practice tips to plan and set up a user survey
- Case study
- PMCF investigation:
- Common pitfalls with PMCF investigation plans
- Case study
- Additional PMCF activities: device registries, electronic health records, social media listening
- Practice with a fictional medical device
Medical writers, Clinical Affairs, Quality Assurance, Product Managers.
Attendees’ experience
This course is intended for personnel with experience in regulatory writing, including PMCF Plans and PMCF Evaluation Reports, under the Medical Devices Regulation 2017/745 (EU MDR).
The workshop will be a mixture of presentations, team discussion, brainstorming and practical examples.
Docente/i
Katharina Friedrich
Katharina Friedrich is a medical writer with experience in MDR regulatory writing. She is based in Heidelberg, Germany and works as a Freelance Medical Writing Consultant with focus on orthopedic and cardiovascular devices. She prepares Clinical Evaluation Plans and Reports, PMCF Plans and Reports and SSCPs in compliance with MDR 2017/745 for class I to class III devices. She also supports development projects and the conduction of PMCF activities. As medical doctor she has experience in the field of orthopedic and trauma surgery.
Online training – 1 module
08 April 2025 from 09:00 am to 1:00 pm CEST
After the registration, 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: € 480,00* until 18/03/2025
Ordinary: € 610,00*
Freelance – Individual – Academy – Public Administration**: € 390,00*
*for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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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.