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:

• Batteries Regulation (EU) 2023/1542
• AI Act (EU) 2024/1689
• Packaging and Packaging Waste Regulation (EU) 2025/40
• European Health Data Space Regulation (EU) 2025/327

You’ll learn:

• About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.
• How to identify all applicable legislation for your product and verify coverage.
• What notified bodies expect to see and the typical level of scrutiny.
• How to structure your compliance register, QMS updates, and regulatory reporting.
• Transition timelines and planning tactics to avoid last-minute surprises.

Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.

Panelists and moderator:

• Greg Griffin, PhD, MRSE – Technical Specialist, BSI
• Claire Burrows – Regulatory Partner, Brabners
• Chris Parr, PMP – Principal, RQM+
• Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)

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