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Transitioning legacy devices from the MDD framework to EU MDR has proven to be more complex than many manufacturers anticipated. Documentation, claims, and clinical evaluations that were previously accepted now require a higher level of clarity, traceability, and supporting evidence under MDR.
For many organizations, the challenge is not just understanding the regulation but identifying where existing approaches fall short when reviewed by Notified Bodies.
This webinar brings a customer perspective on three key challenges that surfaced during MDR transition efforts for legacy devices:
Through real-world experiences, the panel shares how these challenges appeared in practice, where gaps were identified, and what changes helped improve submission readiness.
In this on-demand session, industry experts discuss practical approaches to improving claims clarity, strengthening benefit-risk justification, and building more robust clinical evaluation strategies aligned with EU MDR expectations.
Online Webinar
March 12, 2025 | 10:00 AM ET
During this webinar, our panel discusses practical insights and real-world approaches, including:
Medical & Clinical Strategy Advisor
Julie Jakubowski is an Internal Medicine physician-executive with extensive experience in Medical Affairs and Clinical Development across pharmaceuticals, medical devices, and diagnostics. She spent over 13 years at Baxter International, where she led medical strategy across a $1B portfolio, supporting evidence generation, regulatory strategy, and product lifecycle management.
Vice President of Regulatory Affairs and QMS | Circle Cardiovascular Imaging
Shirantha brings over 32 years of experience in the medical device industry, specializing in regulatory strategy, compliance, and global quality management systems. He has played a key role in scaling regulatory operations and supporting global product registrations aligned with ISO 13485, FDA, and EU MDR requirements.
Managing Director of Scientific Affairs | TMRW Life Sciences, Inc.
Michael Collins is a scientific and medical affairs leader with over 25 years of experience in reproductive health and life sciences. His expertise spans clinical development, regulatory strategy, and scientific communications supporting advanced medical technologies.
Director – Medical Device SME, Celegence
Joseph has over 20 years of experience in medical device lifecycle management and quality systems, including clinical evaluation, regulatory audits, and notified body submissions across global markets.
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