Extended MDR Date of Application: Optimizing your PMS and clinical activities

Now that the European Medical Devices Regulation (MDR) final date of application has been pushed to May 2021, medical device manufacturers should take full advantage of their extra time to ensure their post-market surveillance (PMS) processes will be fully compliant when the Regulation takes effect.

More extensive PMS, post-market clinical follow-up (PMCF) and related clinical requirements of MDR pose considerable challenges for medical device companies. In this one-hour webinar, we will focus on key compliance issues manufacturers should focus on in order to fully utilize the additional time granted before the MDR date of application. We’ll discuss:

• A refresher on MDR PMS and PMCF requirements
• What constitutes “sufficient” clinical evidence for MDR compliance
• Considerations when performing clinical data gap analyses
• Practical considerations and examples of PMS and PMCF activities
• Why and how well-planned post-market surveillance activities could save firms money

ABOUT THE PRESENTER:

Dietmar Falke, PhD heads the Clinical Research team at Emergo by UL. For more than 13 years, Dr. Falke has been involved in or responsible for conducting pharmaceutical and medical device clinical studies. He has wide experience in clinical study product management, from trial design to the generation of the final report, including submission to authorities and ethics committees. In addition, he has significant experience in the interpretation and presentation of study results. Dr. Falke holds a PhD in Microbiology from the Eberhards-Karls-University of Tübingen in Germany. Prior to entering clinical research, he spent several years as a post-doctoral fellow in the department of pharmacology at the University of North Carolina.

This webinar was recorded on July 16, 2020.

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• EU IVDR Gap Assessment and CE Transition for IVD Companies
• EU MDR Compliance Consulting for Cosmetic and Aesthetic Products
• EU Medical Device Vigilance Reporting in Europe
• EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• European Authorized Representative for Clinical Trials
• European Authorized Representative for Medical Device Companies
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• European Union Medical Device Classification
• In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
• IVD Certification and Registration to Obtain CE Marking in Europe
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• Medical Device Technical File and Design Dossier for EU CE Marking
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