Navigating EU MDR Compliance for CE Marking

Date: Thursday, September 12
Time: 12pm-1:15pm PT
Audience: This webinar is recommended for professionals with some familiarity with EU MDR or the previous Medical Device Directive (MDD).
Platform: Zoom

This webinar aims to provide an overall understanding of the critical aspects of EU MDR compliance. Whether you’re preparing for the application (deadline is coming up!) or looking to enhance your knowledge, this session is designed to equip you with the necessary insights.

Key Topics to be Covered:
– EUDAMED and Quality Management System requirements under EU MDR
– Technical documentation requirements for a CE marking submission and how to avoid common pitfalls
– Post-market lifecycle management and reporting

Program Synopsis:
Regulation (EU) 2017/745 (“EU MDR”) has been in force since May 2021, requiring manufacturers of legacy devices to update their quality management systems (QMS) and technical documentation. This webinar will provide a detailed overview of the steps necessary for a successful transition to EU MDR and CE marking. Key topics include interactions with Notified Bodies, project planning, EUDAMED implementation, and QMS and technical documentation requirements, both pre- and post-approval.

With a special focus on the upgrade of legacy devices to MDR, our expert, Dr. Artemis Ailianou, will share case studies and real-life scenarios to illustrate practical strategies and tactics. This will be an invaluable session for anyone looking to understand the intricacies of EU MDR compliance and avoid common pitfalls.

Learning Objectives:
Gain a clear understanding of EUDAMED and QMS requirements under EU MDR.
Learn about technical documentation requirements for CE marking submissions.
Understand the essentials of post-market lifecycle management and reporting.
Don’t miss this opportunity to enhance your knowledge and stay ahead in the ever-evolving regulatory landscape!

About the Speaker:

Artemis Ailianou, PhD, MBA, President, ARTIA RA/QA Consulting Inc

Dr Ailianou is a regulatory affairs and quality system consultant specializing in CE marking and clinical trial applications. She previously worked for a European startup in the ophthalmic space where she led CE marking submission activities for Class IIb implantable devices, approved in 2021 and 2023. She has also managed clinical trial applications in Europe, Canada, and US, securing approvals from competent authorities and ethics committees. Prior to her career in regulatory affairs, she worked in product R&D for novel polymeric materials. Dr. Ailianou earned her BSc in Chemical Engineering from the University of Texas at Austin; her PhD, also in Chemical Engineering, from California Institute of Technology; and her MBA from INSEAD in France.

Free for Member
$20 for Nonmember

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