Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance

Device Advice by RQM+

This show was recorded 28 September 2023 and can be viewed on our website ⁠⁠here⁠⁠. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠. Thank you for tuning in! 🙏

The extension of the EU MDR compliance timeline offers a reprieve for medical device manufacturers, but this extended window comes with its own set of challenges and conditions. As the interim deadlines approach, it’s critical for manufacturers to fully understand their obligations and the ramifications of failing to meet them.

In this high-impact panel discussion, thought leaders from a notified body, manufacturer, and RQM+ come together to unpack the complex landscape of EU MDR compliance in light of Regulation 2023/607 and the transition from MDD/AIMDD to MDR 2017/745.

This is a must-attend session for those dealing with legacy device transitions and meeting upcoming MDR deadlines.

Topics include:

• Understanding key dates: The anatomy of interim deadlines and the conditions for extended transitional arrangements
• Mastering documentation: What manufacturers need to include in their MDR applications for a successful assessment by notified bodies
• Staying compliant: Best practices for incorporating the requirements of MDR 2017/745 into existing Quality Management Systems
• Certificates and self-declarations: Proving the extended validity of your device’s CE certificate and navigating self-declaration protocols
• Risk management: Avoiding common pitfalls that can delay or derail your transition to MDR compliance
• A look into the future: How early compliance can give manufacturers a competitive edge and allow for design and market adaptability

Attendees will leave the session equipped with actionable insights for navigating this complex regulatory environment, including a deeper understanding of the strategic and tactical steps needed for a successful transition.

Panelists:

• Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek
• Brian Dahl – Vice President of Quality and Regulatory, Starkey
• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation, RQM+
• Matt Burger – Vice President, Business Development, RQM+ (moderator)

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