Despite growing complaints that the EU-MDR is choking MedTech innovation, recent regulatory outcomes reveal a more complex truth. Several medium- and high-risk devices, such as Boston Scientific’s ACURATE valve and Becton Dickinson’s Phasix mesh, have earned CE marking under the MDR, yet failed or stalled in the U.S. due to lacking clinical evidence. This article argues that innovation isn’t being stifled by MDR; it’s being redefined through a framework of transparency, post-market evidence, and proportionality. If innovation is struggling, it may be due to resistance against these evolving standards, not the standards themselves.
Approved in Europe, Denied by Data: When Innovation Outruns Evidence
Why this matters?
- Patients: Your access to innovation depends on where you live, not what you need.
- Innovators: The regulatory “fast lane” isn’t always where you think it is.
- Policymakers: The real question isn’t “Who’s faster?”, it’s “Who’s right?”
Introduction: Welcome to the Transatlantic Irony
In an era where regulatory narratives have flipped on their heads, the commonly recited lament that “EU-MDR is stifling innovation” is starting to sound suspiciously one-note. As a former Technical Team Leader at BSI and now as the VP of Global Regulatory Affairs at RQM+, I’ve seen devices hailed as breakthroughs in Europe rejected outright in the U.S. for lack of data. That’s not just irony; it’s a transatlantic regulatory riddle worth decoding.
This isn’t the fringe; it’s happening with headline-grabbing devices. Take Boston Scientific’s ACURATE neo2/Prime transcatheter aortic valve (TAVR), for example. CE-marked under MDR yet tripped on its own clinical data enroute to FDA approval. And that’s just one case.
We’re overdue for a real conversation: Is the EU-MDR really the enemy of innovation, or is it exposing where innovation is outpacing evidence? Is the FDA’s bar the gold standard, or is it sometimes missing a chance to learn from real-world experience? When a prophylactic indication gets approved in the EU with weak data and perhaps conditional post-market surveillance, we have to ask: who’s doing it right?
This article is the counterpoint to the hand-wringing. Let’s dismantle the myth that innovation thrives only where the red tape is thin.
If this is what stifling innovation looks like, maybe we should ask what ‘safe innovation’ actually means.
Approved But Not ACURATE: CE Marked but Clinically Inferior?
Boston Scientific’s ACURATE Prime valve received its CE Mark under MDR in August 2024, after years of use in Europe (Neo, Neo2 versions under the prior directive) and before completion of the pivotal U.S. trial. Of note, there were two earlier randomized controlled trials, SCOPE 1 and SCOPE 2, conducted between 2017 and 2019, where ACURATE failed to meet its primary endpoint. Importantly, CE marking was granted before the IDE trial results were fully analyzed and published. This reveals something more nuanced than a binary approval-failure paradox. Rather than being approved in spite of a failed trial, ACURATE was approved without the pivotal trial at all, highlighting the flexibility, or perhaps vulnerability, of the EU’s risk-based system.
The IDE trial later revealed a 16.1% event rate for ACURATE versus 9.5% for Edwards Sapien and Medtronic Evolut, a significant clinical miss [1]. But by then, the device had already been CE marked. Critically, the post-market story in Europe is richer than a single trial. BSC and its Notified Body can consider real-world evidence (RWE) from thousands of European patients, which may present a different narrative than tightly controlled U.S. trials. That’s both the strength and the question mark of the EU model: earlier access, broader inputs, but sometimes, less certainty.
How is a device that couldn’t match standard-of-care outcomes in a tightly controlled U.S. trial considered safe and effective enough in the EU?
Let’s be clear: innovation isn’t being stifled here. It was perhaps let loose too early. The ACURATE saga illustrates that CE marking, even under the supposedly stricter MDR regime, still permits devices with underwhelming performance, provided there’s sufficient justification and a roadmap for improvement. The FDA, however, isn’t buying it. Clinical evidence mattered more than procedural simplicity or ease of deployment.
Europe gave these devices a head start. The FDA made them prove they were worth it. Both were right and wrong. Approved doesn’t always mean proven. In this case, it means premature.
The Mesh That Slipped Through: Off-Label Data, On-Label Approval
Case in point: the bioabsorbable Phasix mesh. Originally approved for hernia repair, the manufacturer sought to expand the indication to prophylactic use with off-label use data. The expert panel triggered by MDR Article 54 wasn’t thrilled. They cited inadequate long-term data, lack of comparative studies, and concerns from prior safety flags [2].
Yet the device was approved anyway. Notified bodies justified the decision and CE marked the expanded indication albeit with stringent post-market follow-up requirements. The irony? The U.S. FDA would have likely sent that application back with a red pen and a polite “try again.”
This is not a case of MDR throttling innovation. If anything, the system flexed to allow a novel clinical use leveraging off-label use data. It’s exactly the kind of nuanced, market-aware regulation, innovation should thrive under; provided it doesn’t forget the guardrails. And in this case, the MDR relied heavily on transparency and PMCF to de-risk the decision. Whether that’s visionary or reckless depends on what the five-year data reveals.
So, was the EU premature or pragmatic? Ask again in five years if the patients don’t answer first.
Paper Cuts or Patient Wins? When MDR Documentation Becomes the BoogeymanGreen Lights in Europe, Red Tape in the U.S.
Let’s admit it: MDR is a paper monster. The volume of documentation required for compliance can feel punitive. But here’s the twist, it’s not just about red tape for red tape’s sake. Much of this documentation, particularly the periodic safety updates, clinical evaluation reports, and PMCF plans, feeds directly into transparency and accountability. These were deliberate reactions to scandals like the PIP breast implant fiasco and the metal-on-metal hip debacle.
Does this documentation always make a device safer? Not directly. However, driven by the need to meet MDR requirements and Notified Body requests, manufacturers are not only staying close to real-world data but they’re also finding innovative, often creative ways to do so. As a result, we’re seeing outcomes from a broader, more diverse patient population than ever before. And, like it or not, in a competitive landscape, transparency becomes a differentiator. Your competitor may be using their documented outcomes to win over hospitals and health authorities. In the MDR, compliance is a survival skill, and, paradoxically, a tool for competitive innovation.
Transparency might not be convenient, but it just might be revolutionary.
Green Lights in Europe, Red Tape in the U.S.
Comparative looks at how some key devices navigated the EU vs. U.S. regulatory gauntlet: one eventually found shelter in FDA’s house, but the rest are still knocking or napping on the porch.
| Device | EU Status | FDA Status | Evidence Gap | MDR Risk Class |
| ACURATE neo2 and ACURATE Prime (Boston Scientific) | CE Marked (MDR) (2024) | IDE trial failed, 2 other RCTs failed; not approved, currently | Failed non-inferiority endpoint | Class III |
| Phasix Mesh (BD) | CE Marked (2024, prophylactic use) | No FDA indication expansion | Weak long-term, non-comparative data | Class III |
| Neovasc Reducer (Shockwave) | CE Marked (2011) | Rejected by panel (2020); new U.S. trial ongoing | Small trial, subjective endpoints | Class III |
| neuroAD System (Neuronix) | CE Marked | Rejected in 2019 | No benefit over sham in RCT | Class IIb |
| M6-L Disc (Orthofix) | CE Marked (2006) | Never submitted (the lumbar version) | No FDA trial; costly IDE requirements | Class III |
| CMR Versius Robot | CE Marked (2019) | FDA cleared in 2024 (De Novo) | Delay due to pathway complexity | Class IIb |
Each of these cases presents a lesson in regulatory divergence, not deficiency. Innovation wasn’t blocked in Europe; it was conditionally allowed, often with rigorous follow-up commitments. The U.S. path, meanwhile, demanded premarket certainty.
Some devices fly on real-world experience, others stall on missing data. The runway you choose matters.
What the Next Decade of Innovation Needs from RegulatorsConclusion: Innovation Demands Evidence, Not Expediency
As MedTech complexity accelerates, the regulatory frameworks that govern them must evolve; not just to keep up, but to lead responsibly. The future belongs to systems that reward designed-in evidence, not post-hoc justifications. Regulators must double down on:
- Data interoperability: Leveraging international real-world evidence (RWE) and post-market registries.
- Global convergence: Aligning on definitions, endpoints, and risk thresholds across FDA, EU, and IMDRF partners.
- Modular approvals: Enabling conditionally approved indications tied to PMCF or additional cohorts.
To serve patients and foster meaningful innovation, we must move from regionally bounded decisions to globally informed regulation. The EU and U.S. don’t need to match timelines, they need to align on what good evidence looks like.
But here’s another wrinkle worth unpacking: Clarity.
In the U.S., manufacturers can proactively engage the FDA, receiving structured feedback on clinical strategy, trial design, and evidentiary expectations through formal mechanisms. In the EU, manufacturers of high-risk devices may approach the Expert Panel for guidance, but those comments are non-binding. The final authority lies with the Notified Bodies, and this is where the real structural tension emerges. Unlike the FDA, which is a single regulatory body, the EU relies on a decentralized network of Notified Bodies. If they were allowed to offer binding clinical strategy guidance, it would create a competitive incentive to “go easy”, undermining consistency and lowering the bar. As a result, manufacturers are left to guess at expectations and over-engineer technical files just to hedge against opacity.
So we have to ask: is innovation slowed by the quantity and quality of evidence, or by the uncertainty of what will be accepted? That ambiguity doesn’t just delay timelines; it distorts strategy. If the next decade of innovation is to thrive, regulators must pair rigor with transparency. Otherwise, we’re not regulating innovation; we’re gambling with it.
Conclusion: Innovation Demands Evidence, Not Expediency
The idea that EU-MDR stifles innovation has become regulatory folklore. But look closer, and the story crumbles. CE-marked devices like ACURATE and the Phasix mesh prove that the MDR still makes room for innovation, sometimes at the expense of rigor. Meanwhile, the FDA’s higher bar keeps certain innovations out, but not always unfairly.
Innovation doesn’t thrive in a vacuum or an absence of regulation. It thrives in proportionate, informed, and evidence-driven environments where transparency isn’t optional, and real-world outcomes matter more than regulatory shortcuts.
The MDR isn’t perfect; it’s bureaucratic and resource-intensive. But it’s also trying to do something regulators rarely do: demand proof without stalling progress while emphasizing transparency. If innovation is being stifled, perhaps it’s not by regulation but by the refusal to meet its rising expectations. Maybe just maybe, the real innovation isn’t the device itself; it’s designing clinical evidence into the blueprint, not bolting it on after launch.
Regulators aren’t gatekeepers of progress. They’re stewards of trust. And trust like data can’t be faked. If we want innovation that matters, we must stop blaming the rulebook and start rewriting the playbook.
The future of MedTech won’t be written by those who got there first; it will be written by those who proved they belonged.
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