- within Food, Drugs, Healthcare and Life Sciences topic(s)
In the latest Digital Health Miniseries episode of Greenberg Traurig’s Big Law Redefined Podcast, host Charles Dunham is joined by GT Berlin and Munich colleagues Dr. Christian Rybak and Julian Bartholomä for a deep dive into what it takes to enter and compete in the European health care market. With the EU Medical Device Regulation still presenting significant implementation challenges, new AI rules entering into application, and targeted reforms of the MDR under discussion, the regulatory landscape for digital health, MedTech, and life sciences companies continues to evolve, making now the right time to reassess EU strategies.
Their discussion opens with a survey of the current regulatory landscape and explains why the EU's conformity-based, multiauthority system differs fundamentally from the FDA's centralized pre-market approval model. The guests walk listeners through the two distinct hurdles every company must clear: obtaining CE marking and then navigating reimbursement on a country-by-country basis across the 27 member states.
Product classification emerges as the single most critical first decision, with the guests explaining how an incorrect risk classification can expose a company to regulatory enforcement, unfair competition litigation, and significant commercial setbacks. Their conversation addresses why reimbursement strategy must be integrated into clinical development from the outset and how the evidence standards required by payers differ from those required for regulatory approval.
The episode closes with actionable guidance for companies planning their EU market entry, including how to select and build early relationships with notified bodies, why Germany often serves as the preferred initial launch market, how Germany's DiGA pathway offers a structured reimbursement route for digital health applications, and how direct contracting with (statutory) health insurers can accelerate market access in certain situations.
Throughout, they emphasize that the best positioned companies are those that align their regulatory, reimbursement, and commercial strategies from day one.
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