
This panel was recorded September 18, 2025. We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at RQMplus.com.
Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.
In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.
We cover practical implications of recent and emerging regulations, including:
You’ll learn:
Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.
Panelists and moderator:
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