The inaugural issue of EU MDR & IVDR Insider is here, providing practical resources and expert guidance for medical device and IVD manufacturers. This issue highlights Article 10a compliance ahead of the January 10, 2025, deadline and offers insights into regulatory requirements for orphan devices. Download the full PDF issue>>
Hereā€™s what youā€™ll find in this edition:
Update: Welcome to the Inaugural Issue
By Bassil Akra, PhD
Dr. Akra reflects on the significance of Article 10a and the steps manufacturers must take to achieve compliance. This editorial sets the tone for the issue, emphasizing actionable guidance and collaboration.
This issue equips manufacturers with the tools and knowledge to tackle Article 10a and beyond. Dive into the resources, explore the blogs, and register for upcoming events to stay ahead in regulatory compliance.
Feature: What You Need to Know About Article 10a
By Lawrence Yeh
This in-depth article unpacks the responsibilities Article 10a introduces for manufacturers, economic operators, and notified bodies. From supply chain obligations to updates in quality management systems, learn how to meet these requirements and stay compliant.
Webinar Recording
Missed the live webinar on Article 10a? Access the recording, full transcript, and slides to benefit from the insights Erik Vollebregt, Bassil Akra, and Lawrence Yeh shared. The session also includes the Top 10 Questions Submitted by the Audience, answered in detail.
Articles: Expert Insights
Explore additional articles breaking down the practical implications of Article 10a across roles and responsibilities:
- Legacy Device Manufacturers and Article 10a: Key updates for legacy device compliance and avoiding regulatory pitfalls.
- Quality Management Systems and Article 10a: Practical steps to ensure your QMS achieves Article 10a compliance.
- Economic Operators and Article 10a: Understanding new responsibilities for importers, distributors, and authorized representatives.
- What Notified Bodies Need to Know About Article 10a: The expanded role of NBs in assessing compliance and supporting manufacturers.
Actionable Resources
- Article 10a Decision Tree and Worksheet: A practical tool to help manufacturers assess their obligations and streamline compliance efforts.
- Official Guidance: Access MDCG documents and European Commission Q&A for additional support.
Upcoming Events
Join us on January 21, 2025, for a live webinar:
EU Orphan Devices: Regulatory Pathway and Clinical Evidence Requirements
Panelists Richard Holborow, Nebojsa Serafimovic, and Matthias Fink will discuss the criteria for orphan device designation, accelerating patient access, and strategies for clinical evidence.
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