RQM+ Live! #89 – Compliance for EU Market Access: An actionable panel featuring BSI, Brabners, and RQM+
RQM+
01:02:17
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:
- 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, BSI
- Claire Burrows, Brabners
- Chris Parr, RQM+
- Jaishankar Kutty, RQM+
A certificate of attendance is available upon request for live attendees.
Speakers
Claire Burrows
Regulatory Partner, Brabners
Greg Griffin, PhD, MRSE
Technical Specialist, BSI
Chris Parr, PMP
Principal, RQM+
Chris Parr is a seasoned regulatory leader with 20+ years in the MedTech and pharmaceutical sectors. With a background in natural sciences, he offers deep expertise in regulatory affairs, quality management systems, risk management, design controls, and project management. He has led global teams, delivered complex projects in both industry and consulting, and is highly skilled in implementing the EU MDR and other EU legislation. Chris has worked directly with major regulatory bodies, including the US FDA, Health Canada, EU Competent Authorities, and Notified Bodies.
Jaishankar (Jai) Kutty, Ph.D.
Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)
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RQM+ Live! #89 – Compliance for EU Market Access: An actionable panel featuring BSI, Brabners, and RQM+
01:02:17