How your PMCF is evaluated by your Notified Body? [Matthias Fink]
PMCF is something that was existing before with MDD 93/42/EC but this is more in focus now with the new EU MDR 2017/745. In this episode, I have invited Matthias Fink from TÜV SÜD to help us understand some of the mistakes we are making in the creation of our PMCF. He will tell us what to do and how to distinguish between the different PMCF types.
Who is Matthias Fink?
Board-certified orthopedic and trauma surgeon with 17 years of experience in orthopedic, trauma, and reconstructive surgery and extensive training in cardiovascular and thoracic surgery. Working for TÜV SÜD Product Service in Germany since 2016 as a Clinical Reviewer in the Clinical Centre of Excellence before joining TÜV SÜD America in 2017. Senior Clinical Expert Orthopedic Surgery for the Clinical Centre of Excellence and the Team Manager of the Clinical Focus Team North America. Presenter at national and international conferences and workshops on the clinical requirements and the implementation of the EU MDR.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…
- Matthias Fink LinkedIn Page: https://www.linkedin.com/in/matthias-fink-47a3b227/
- MDCG PMCF plan 2020-7: https://ec.europa.eu/health/document/download/a5cdb303-c782-4010-8723-7d389af678f7_en
- MDCG PMCF report 2020-8: https://ec.europa.eu/health/document/download/11121036-696a-4589-a311-c5525bd84df3_en
- TÜV SÜD Medical and Health Care LinkedIn Page: https://www.linkedin.com/showcase/tuvsud-medicaldevices/
- Application page for MDR services: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration
- Information on the clinical data requirements under the MDR: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/clinical-services/clinical-data-for-medical-devices
- A search engine of the TÜV SÜD resource center with webinars and published white papers: https://www.tuvsud.com/en-us/resource-centre