Starting with CE in Europe and then moving on to the US is no longer the case. In practice, that logic is changing.
More and more Nordic companies are reporting that FDA is perceived as more predictable and dialogue-driven than CE under MDR, especially in SaMD and AI. This does not mean that CE has become irrelevant, quite the opposite. But it does mean that the most successful companies are no longer thinking sequentially, but in parallel.
“A global strategy is not about choosing a market – it’s about choosing the right logic.” – Paulina Jonasson, CEO and Regulatory Affairs, Medtech Maze.
Global regulatory strategy is not about doing everything at once. It's about designing the product, documentation and structure to work for multiple markets from the start.
CE is the foundation – but no longer the only logic
CE marking under the MDR remains a key milestone for European companies. It is crucial for healthcare procurement, clinical legitimacy and long-term presence in the EU.
At the same time, many companies today experience that processes can be long, interpretations differ between notified bodies, lack of capacity creates queues, and that the requirements for software and AI are not always perceived as concrete enough.
In parallel, many describe the FDA as more dialogue-based, clearer in its expectations, especially mature for SaMD and algorithms, and consistent in how requirements are applied.
The conclusion is not that CE should be de-selected. The conclusion is that CE is no longer the only regulatory logic that shapes early decisions.
FDA is perceived as easier because the requirements are clearer – not because the bar is lower
In practice, many companies experience the FDA as more predictable, not because the requirements are lower, but because they are clearer and earlier in the process.
The FDA is based on certain basic questions being answered from the start, including:
- The area of application is clearly and consistently defined
- Design controls are systematic and traceable
- Risk management is actively used as decision support
- Verification and validation are kept separate in the right way
- Code, data and algorithms can be followed throughout the development
- Dialogue with the authority (pre-sub) takes place in good time
It is precisely this clarity that is causing more and more European companies to use the FDA logic as a way to structure their CE work, even when Europe is intended as the first market.
Avoid design lock-in – build modularly from the ground up
One of the biggest regulatory risks today is not the regulations themselves, but design lock-in.
When companies build too narrowly on an interpretation of MDR, they risk:
- Need to redo documentation for FDA
- Adjust clinical studies afterwards
- Lock down the product architecture
A global strategy instead requires modularity. This means that:
- Functions can be changed without the entire CE basis falling
- Clinical studies are designed for multiple markets
- Risk management is kept general
- Documentation is built block-based
- The product can be adapted without regulatory change
This isn't more work, it's smarter architecture.
Four pillars for a global regulatory strategy
Pillar 1 – CE and FDA on the same map
Visualize overlaps and differences early. This results in better prioritization and fewer surprises. When the team shares the same regulatory map, it becomes clearer which decisions are global and which are market-specific.
Pillar 2 – Market-agnostic clinical plan
Design evidence that works in both the EU and the US. Then you don't have to redo it. A common clinical logic means that every study builds long-term value, regardless of which market comes first.
Pillar 3 – QMS built to grow
Start simple, but choose a structure that can be raised to FDA level without rebuilding. A scalable QMS reduces future friction and allows the organization to grow without the quality system becoming a brake.
Pillar 4 – Future-proof product architecture
Build for change: upgrades, new features and new markets, without starting over regulatory. When architecture and documentation are modular, the product can evolve with the business, not be limited by previous decisions.
Summary
Companies that think about global regulatory strategy early build faster scalability, lower regulatory risk and greater freedom of action over time. CE and FDA are not competing tracks, they are parts of the same strategic map for companies that want to grow internationally. When regulations are designed for multiple markets from the start, re-use is reduced, capital is tied up more effectively, and the path to the next market becomes an adaptation, not a restart.
This article is part of our series on how regulation interacts with business strategy, investments, teams and global growth in medtech companies. If you want a solid foundation in what CE marking is, why the regulations exist and how the process works in practice, we also recommend our introductory article: “CE marking: what it is, why it exists and how the process actually works.”