Inside Europe’s digital health market: Big Law Redefined podcast breaks down MDR, CE marking, and reimbursement strategy

Entering the European market has become both more attractive and more complex for digital health, MedTech, and life sciences companies. That is the central message from a recent episode of Greenberg Traurig’s Big Law Redefined podcast, part of the firm’s Digital Health Miniseries. Host Charles Dunham, a corporate health care attorney and shareholder in GT’s Houston office, spoke with Dr. Christian Rybak, Shareholder in the Public Law Group in Germany and Chair of the German Health Care & Life Science Practice, and Julian Bartholomä, Local Partner in the Public Law Group in Germany, about what companies need to understand before committing resources to EU expansion.

According to Rybak, several regulatory shifts have converged to make this a pivotal moment for market entry. The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have significantly raised the evidentiary and compliance bar. Artificial intelligence and software-based products are facing heightened regulatory scrutiny, and cybersecurity has moved from an afterthought to a core regulatory requirement. At the same time, Europe remains one of the largest and most valuable health care markets in the world, making it a priority for companies with global ambitions.

Bartholomä added that the MDR transition period has largely concluded, bringing more regulatory clarity. New guidance has been published on the classification of software as a medical device, and a new EU AI regulation has recently taken effect. Rybak also noted that a proposed revision to the MDR was submitted by the European Commission in December 2025, meaning further regulatory change is already on the horizon for companies planning multi-year market entry strategies.

Dunham, moderating the discussion, framed why this level of detail matters beyond the legal team. For research and development leaders and investors deciding whether to back a European expansion, having a clear view of the regulatory roadmap over a 1-, -2-, or 3-year horizon is critical to securing funding and setting realistic timelines.

Key differences between the US and EU regulatory systems

For companies accustomed to the FDA’s centralized approach, the EU system requires a mindset shift. Bartholomä explained that while the United States uses a single federal agency for premarket approval and clearance, the EU relies on a decentralized, multi-layered structure. Medical devices are assessed not by a single central authority but by independent organizations called notified bodies under the MDR.

Securing the CE mark, which allows a product to be placed on the EU market, is only the first step. Reimbursement decisions are made separately, on a country-by-country basis, each with its own competent authorities and evidentiary expectations. Rybak emphasized that this two-track system, market access first and reimbursement second, requires more strategic planning than companies typically anticipate coming from the US market.

Understanding the CE mark: What it does and does not mean

One of the most persistent misconceptions among companies entering Europe is what the CE mark actually signifies. Bartholomä was direct on this point: the CE mark does not guarantee reimbursement anywhere in the European Union. It confirms that a product complies with the applicable EU legislation for its risk class and can legally be sold in the market.

Rybak described the CE mark as a legal conformity marking rather than a quality or clinical endorsement. It signals that the manufacturer has verified, often with the support of an independent notified body, that the product meets essential safety and performance requirements and has completed the required conformity assessment procedure—nothing more, and nothing less.

Getting product classification wrong from the outset carries real consequences. Both attorneys pointed to a wave of litigation in Germany in recent years, where competitors have challenged companies that self-registered lower-risk software products as Class I medical devices without going through a notified body. Misclassification can trigger regulatory enforcement, competition law claims under Germany’s Unfair Competition Act, and the loss of reimbursement eligibility entirely.

Why reimbursement strategy should start during clinical development

A common theme throughout the discussion was timing. Rybak stressed that the evidence needed for CE marking is often different from the evidence payers require for reimbursement. Regulators want proof of safety and performance, while national payers and social security funds want proof of clinical benefit, improved outcomes, and value for money.

Companies that wait until after receiving the CE mark to think about reimbursement often discover they generated the wrong evidence and need to run additional studies, adding cost and delay. Bartholomä noted that the pharmaceutical industry has long understood this and builds reimbursement considerations into clinical development from day one. Digital health startups, many of which are smaller and less experienced in navigating health care markets, often have not, making early legal and regulatory guidance especially valuable.

A practical roadmap for country by country market entry

When it comes to sequencing EU market entry, Bartholomä recommended starting with the largest and most structured markets. Germany is frequently the first stop, partly due to its economic size and partly because it was among the first countries to create a formal reimbursement pathway for digital health applications, known as DiGAs, which can be prescribed and reimbursed through statutory health insurance.

Rybak cautioned against viewing DiGA reimbursement as a true shortcut, noting the term fast track can be misleading since it does not bypass regulatory requirements. The more useful question, he said, is not which country allows the fastest launch, but which launch sequence optimizes both market access and long-term value across the entire European market. Answering that question requires coordinating regulatory, reimbursement, legal, and commercial strategy together rather than in isolation.

Bartholomä also pointed to an alternative strategy used in Germany: negotiating direct contracts with individual statutory health insurers rather than pursuing broader nationwide reimbursement, which can be a faster route to market for companies that need to move quickly.

Dunham offered a useful point of comparison from his own experience advising clients on the US side. He noted that the US market is often criticized for being fragmented, since clearing FDA hurdles does not guarantee government or commercial payer reimbursement once a product reaches the market. Hearing how certain European countries, Germany in particular, offer more clearly defined fast-track pathways for authorization and reimbursement gave the conversation a practical, side-by-side view of where the two systems actually diverge and where they share similar underlying logic.

First 90 days: practical takeaways for companies planning EU entry

For companies mapping out their first steps, both attorneys offered concrete advice. Bartholomä recommended starting with a rigorous self-assessment against the MDCG guidelines to determine the correct risk classification before taking any other action, since misclassification can lead to costly litigation and forced market withdrawal down the line. Where a notified body is required, and it typically is for software as a medical device, building that relationship early and aligning on timelines and documentation requirements can significantly smooth the path to certification. Not all notified bodies are the same, and choosing one suited to a company’s size and product type matters.

Rybak’s closing advice centered on strategy sequencing: companies should build a market access strategy, not just a regulatory one. That means understanding likely classification early, engaging regulators and stakeholders proactively, and designing clinical programs that satisfy both CE marking requirements and payer evidence expectations from the start.

The bottom line for digital health and MedTech companies eyeing Europe

Europe continues to offer a significant opportunity for digital health, MedTech, and life sciences companies, but success depends on far more than obtaining a CE mark. Companies that align regulatory strategy, clinical evidence generation, and reimbursement planning from the earliest stages of product development are best positioned to avoid costly delays and achieve sustainable market access across the region’s fragmented but lucrative health care landscape.

This is a summary by MedTech World, based on the Big Law Redefined podcast episode from Greenberg Traurig’s Digital Health Miniseries.

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