Jeanette Demorney
Senior Advisor, Clinical Development – GBA Key2Compliance
One of the most common statements you hear in MedTech right now is that MDR is simply too complex.
It is often described as bureaucratic, unpredictable, and overly demanding, particularly for small and mid-sized companies. For many, the regulation itself has become the explanation for why products struggle to reach the market.
But when you look at product development projects more closely, a different picture often emerges. In many cases, the real challenge is not the complexity of MDR. It is that the clinical strategy was never clearly defined in the first place.
The Wrong Question:
“What Clinical Study Do We Have to Do?”
One of the most common questions companies ask when approaching CE marking is:
“What clinical study do we have to do?”
It is a natural question, and an understandable starting point. But it often reflects an approach where clinical evidence is seen mainly as a regulatory requirement towards the end of development, rather than as something that helps define the product’s value and should inform development from the beginning.
Before discussing study design, a number of more fundamental questions need to be addressed. Many of the answers to these questions emerge through the clinical evaluation and State of the Art. The clinical study then becomes one element within a broader clinical strategy, not the starting point.
- What clinical problem are we actually solving?
- What change should the user or patient experience?
- How strong does the evidence need to be for clinicians to trust the product, for investors to fund it, and for the market to adopt it?
When these questions remain unclear, the clinical plan often follows the same risky pattern.
When Strategy Is Missing, MDR Becomes the Scapegoat
Without a clear clinical position, studies are often planned with the ambition to keep them as small and manageable as possible. What many companies underestimate is how demanding even a relatively small clinical study can be in terms of time, resources, and investment.
At the same time, endpoints are sometimes defined without a clear connection to the clinical evaluation and the current State of the Art. As a result, the study may lack the line of reasoning that links the clinical problem, the intended benefit, and the evidence being generated. At that point, MDR is often perceived as the problem.
Under the previous directive, many products could rely heavily on literature, equivalence, and technical reasoning. MDR raised the expectations. Companies are now expected to demonstrate how intended purpose, risks, performance, and clinical outcomes are connected.
This also means that the clinical evaluation, study design, and chosen endpoints need to follow the same clinical logic. What is often described as regulatory complexity is, in many cases, simply a demand for greater clarity.
The False Economy of “Minimal” Clinical Evidence
As mentioned, a recurring pattern in struggling projects is the attempt to optimise for the smallest possible study at the lowest possible cost. On paper, this seems rational. In practice, it often leads to requests for additional data, redesigned studies, and significant delays.
In a capital-intensive industry, time is often the most expensive variable. A weak study rarely saves money. instead, it usually just postpones the real cost.
At the same time, more companies are gradually beginning to take a broader view of clinical strategy. Even for lower-risk devices, they may decide to generate clinical data when it helps reduce regulatory uncertainty, support investor discussions, or strengthen credibility with clinicians.
For these companies, the clinical strategy is not only about compliance.
It is part of the business strategy.
From Navigating MDR to Owning Clinical Value
MDR is not perfect, and the system still faces structural challenges. But describing the regulation as simply “too complex” risks becoming a convenient explanation for deeper strategic gaps.
The more productive question is whether the product has a clearly defined clinical position, and whether the evidence plan was built around that position from the start.
Companies that define their clinical value early, design studies around meaningful outcomes, and think in terms of an evidence lifecycle rather than a single approval step tend to move more smoothly through MDR. They also tend to attract capital more easily and gain clinical acceptance faster.
If European MedTech wants to remain competitive, the conversation needs to shift. The key question is not how to survive the complexity of MDR, but how to build clinical strategies strong enough to make that complexity manageable.
When clinical strategy becomes a core business decision, fewer development projects stall — and more technologies reach the patients they were designed to help.
How We Can Help
We work with MedTech companies to build clinical strategies that stand up to MDR scrutiny while supporting long-term business goals.
From early clinical positioning and evidence planning to study design and regulatory alignment, we help teams move from reactive compliance to confident decision-making.