⏺️ Recorded September 18, 2025
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 will 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 attend: 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)
A certificate of attendance is available upon request for live attendees.
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