Expert Class recap: navigating EU MDR with confidence
On 13 February 2026, LifeSciences@Work hosted an Expert Class at Axon Lawyers in Amsterdam, focused on navigating the European Medical Device Regulation (MDR) and related regulatory frameworks.
The session was opened by Leon (Iventus) and Lynn van der Zwan (Health~Holland), who introduced the Life Sciences & Health ecosystem context and the importance of integrating regulatory strategy early in product development.
Understanding the regulatory landscape
Judith de Wilde provided an overview of the evolving European regulatory landscape and its implications for MedTech innovators. She addressed European competitiveness, as well as the importance of clearly defining intended purpose and correct classification under MDR and IVDR from the outset of development.
Erik Vollebregt structured MDR compliance around four core elements:
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Quality Management Systems and document control
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Design control as the backbone of traceable development
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Clinical evaluation
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Horizontal legislation, including broader regulatory requirements
The session highlighted how regulatory considerations must be embedded from day one to ensure a viable pathway to CE marking and market access.
From compliance to certification
Huibert Tjabbes concluded the afternoon with practical insights into certification processes and the steps required to move from development to CE marking.
The Expert Class provided practical guidance for founders, regulatory professionals and product leads working to bring medical devices and IVDs to market in the EU.
LifeSciences@Work Expert Classes are small-scale, targeted workshops organised in close collaboration with industry experts. They are primarily intended for Venture Challenge alumni and early-stage startups within drug development, medical technology, diagnostics and enabling technologies.
