Smarter CER Maintenance: Achieving Efficiency, Consistency, and ROI with AI
Overview
Where
Online Webinar
When
10:00 AM – 11:00 AM ET
Webinar Overview
For many medical device manufacturers, transitioning legacy products from the MDD framework to EU MDR has uncovered unexpected challenges. Teams that believed their documentation, claims, and clinical evaluations were well established often found that the MDR requirements demand a different level of clarity, structure, and supporting evidence.
In this webinar, regulatory leaders will share a practical customer perspective on three challenges that surfaced during MDR transition efforts for legacy devices. Rather than focusing on theory, this session walks through what actually happened inside a manufacturer’s regulatory workflow — where documentation gaps appeared, why Notified Bodies raised questions, and how those challenges were addressed.
The discussion will focus on 3 key areas many manufacturers struggle with today:
- Differentiating clinical benefit vs. technical benefit in claims documentation
- Building a defensible benefit-risk profile aligned with GSPRs
- Strengthening clinical evaluation through structured SLRs, SoTA analysis, and evidence hierarchy
Attendees will gain a clear view of how these issues appear in real projects, what regulators expect, and how manufacturers can approach MDR documentation with greater confidence and clarity.
Learning Objectives
By attending this webinar, participants will learn:
- Why manufacturers often confuse clinical claims and technical performance claims, and why this matters under MDR
- How to structure GSPR mapping and benefit-risk justification with traceable and quantifiable evidence
- What has changed in clinical evaluation expectations under EU MDR, including SoTA, equivalence, and level of evidence
- How structured systematic literature reviews (SLRs) support defensible CERs
- Practical lessons from a manufacturer who went through this transition and the impact it had on their regulatory strategy
Discussion Points
Challenge 1: Clinical Benefit vs Technical Benefit
Many manufacturers discover during MDR transition that existing claims mix technical performance statements with clinical benefit claims. Regulators expect these to be clearly differentiated and supported with appropriate evidence.
This discussion will explore how manufacturers can classify claims correctly, map them to GSPR requirements, and identify gaps in clinical justification before submission.
Challenge 2: GSPR Mapping and Benefit-Risk Justification
Under EU MDR, benefit-risk determination must be clearly defined and supported by traceable evidence. For teams transitioning from MDD workflows, this often requires new documentation practices.
The panel will discuss how manufacturers can strengthen benefit-risk profiles by linking clinical benefits, risks, SLR findings, and post-market data to specific GSPR requirements.
Challenge 3: Clinical Evaluation: State-of-the-Art, Equivalence, and Evidence Levels
EU MDR clinical evaluation expectations go beyond document updates. Manufacturers must justify state-of-the-art positioning, demonstrate equivalence under stricter criteria, and determine appropriate clinical evidence levels for each device.
This discussion will cover practical approaches to conducting defensible SLRs, evaluating equivalence strategies, and aligning clinical evidence with CER requirements.
Who Should Attend
This webinar is designed for professionals involved in EU MDR compliance and clinical evaluation for medical devices, including:
- Regulatory Affairs Leaders
- Clinical Evaluation Specialists
- Medical Writers working on CERs
- Quality and Compliance Leaders
- PMS / PMCF Program Managers
- Clinical Affairs and Evidence Generation Teams
It is particularly relevant for organizations managing legacy devices transitioning from MDD to EU MDR.
Why Attend
Participants will gain insights from real regulatory challenges experienced by a manufacturer, including how teams addressed documentation gaps, improved claims clarity, and strengthened clinical evaluation strategies.
The session provides practical takeaways that regulatory teams can apply when preparing MDR documentation or responding to Notified Body expectations.
Webinar Speakers
Medical & Clinical Strategy Advisor
Julie Jakubowski, MD, FACP
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. Julie has also served as Assistant Professor of Medicine at Northwestern Memorial Hospital and has published in areas including metabolic disease, nutrition, and digital medicine.
Webinar Moderator
Director - Medical Device SME, Celegence
Joseph Richardson Larbi
Joseph has 20 years' experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025). Key experience includes preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE and notified body opinion submissions. Joseph has worked on diabetes management devices, nicotine replacement therapy (NRT) devices and pressurised metered dose inhalers (pMDI); Joseph has worked for small, medium and large Biotech companies such as Roche, OBG Pharmaceuticals and Kind Consumer Ltd.
Where
Online Webinar
When
10:00 AM – 11:00 AM ET
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