The Second Issue of EU MDR & IVDR Insider is Here
Providing expert insights and practical resources for medical device and IVD manufacturers.
This issue covers the latest updates on orphan devices, critical regulatory changes, and a major initiative that could transform clinical trials in the EU.
What’s Inside This Edition:
Update: Welcome to the Second Issue
By Bassil Akra, PhD
Dr. Akra explores key regulatory shifts, including the European Commission’s pilot program for clinical trial assessments and the latest MDCG guidance on orphan devices.
Feature: Industry Experts on Orphan Devices – Tom Melvin Interview
Interview with Tom Melvin – Why Orphan Devices Matter and What Needs to Change
We spoke with Tom Melvin, regulatory expert and former European regulator, about the critical role of orphan devices, the potential of the Orphan Device Program, and why many companies overlook opportunities in this space.
Key insights include:
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How EU MDR has accelerated the disappearance of essential devices, particularly in pediatric cardiology.
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Why financial concerns prevent manufacturers from pursuing orphan devices—and why that’s a mistake.
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The DeCODe Project, which is working to remove barriers to orphan device approvals.
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The urgent need for structured clinical pathways and regulatory incentives to prevent life-saving devices from vanishing.
5 Insider Perspectives on Orphan Devices
We also gathered insights from top industry experts on how to overcome regulatory, financial, and clinical challenges in orphan device development:
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Steve Eglem (Former European Commission, Belgium) – The need for regulatory incentives and financial support to bring orphan devices to market.
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Marianna Mastroroberto (KIWA ITALIA) – Why manufacturers must take a risk-based approach when clinical trials are not feasible.
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Philippe Auclair (GHWP TC advisor, RAPS Fellow) – How improved post-market data collection can support safer adoption of orphan devices.
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Ralf Klein (Radimed GmbH, MDCG TF Orphan Devices, RA Spectaris) – The importance of extrapolating clinical data from existing products to streamline approvals.
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Stephen Gilbert (Else Kröner Fresenius Center for Digital Health, Germany) – How current regulatory systems create unintended barriers for niche medical technologies.
Webinar Recording
EU Orphan Devices – Regulatory Pathway & Clinical Evidence Requirements
Did you miss the live webinar featuring Matthias Fink, Gavin Quigley, and Nebojsa Serafimovic?
Access the full recording, transcript, and slides for insights into:
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The orphan device regulatory framework and qualification criteria.
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Strategies for accelerating notified body approvals.
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MDCG guidance on clinical data requirements and alternative evidence pathways.
Articles: Expert Insights on Regulatory Challenges
Explore our latest expert articles covering key regulatory and compliance updates:
- Understanding the Orphan Device Framework – What’s new in EU orphan device regulations and what manufacturers need to know.
- Why Orphan Devices Present Unique Market Opportunities – The business case for orphan devices and how to navigate MDR efficiently.
- The Process: How to Apply for Orphan Device Status – A step-by-step guide to eligibility, regulatory engagement, and clinical evidence preparation.
- Overcoming Challenges: What Manufacturers Need to Consider – Managing costs, regulatory hurdles, and risk assessments.
- Real-World Adoption of Orphan Devices: Early Trends and Case Study – First movers in orphan device approvals and what’s shaping the market.
Upcoming Webinars & Training
Stay ahead in compliance by attending these expert-led sessions:
📅 March 4 – Clinical Evaluation Training
📅 March 20 – SSCPs Online Training
📅 March 27 – PMS, PMCF & PSUR Training
📅 June 24-25 – Quality Accelerator Program – Save the Date!
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