One Product, Two Systems: Why Regulatory Divergence is Slowing MedTech Innovation

Introduction

For many MedTech startups, expanding into both the US and EU feels like a natural goal. On paper, the product is ready. The team has done their clinical homework. Maybe the FDA 510(k) is already in progress. Surely the EU version of the submission should follow closely behind? 

In reality, it’s rarely that simple. While both the FDA and EU MDR frameworks aim to ensure safety and performance, the divergence between them has become increasingly difficult to manage. This can cause delays, confusion, and in some cases, derail promising product launches altogether. 

Working across both systems, I’ve seen the impact firsthand from the regulatory driving seat. Small and mid-sized companies, especially those without large regulatory teams, are spending more time managing classification mismatches, duplicative evidence demands, and unpredictable timelines than actually getting their devices into the hands of clinicians and patients. Apart from being a regulatory inconvenience, it’s also a frustrating barrier to innovation. 

The Promise of a Global Strategy Meets a Fragmented Reality

Founders and innovators often start with a clear international ambition: develop one product, access two major markets, and scale from there. The challenge is that the level of divergence between the EU and US regulatory environments has grown to a point where parallel submissions now resemble two separate product development pathways. 

Under the US FDA, predictable routes like the 510(k) and De Novo processes are supported by defined review timelines and the option of early Q-Sub (Pre-Sub) meetings. In contrast, the MDR, particularly under Article 61 and Annex XIV, requires more extensive justification of clinical evidence, even for legacy or moderate-risk devices. Notified Bodies are also facing resource constraints that have led to unpredictable timelines. 

The burden of this complexity falls most heavily on SMEs, who must choose between delaying one market, overextending their internal team, or spending limited capital on external support. 

Three Friction Points Holding SMEs Back

1. Evidence Expectations

A major pain point is the divergence in evidence requirements. Under the FDA’s 510(k) process, many moderate-risk devices achieve clearance through bench testing, risk analysis, and demonstration of substantial equivalence to an existing predicate (a product that is already on the market). Clinical data may not always be required. 

By contrast, MDR expectations are broader. Article 61 requires manufacturers to justify the sufficiency of existing clinical evidence. In practice, this often leads to Post-Market Clinical Follow-Up (PMCF) demands or even full clinical investigations, even when the same device has already been cleared in the US. 

One company I supported had successfully achieved FDA clearance for a wearable diagnostic device based on bench testing and usability validation. When preparing for EU submission, we discovered the Notified Body would likely request a detailed Clinical Evaluation Report supported by human data. Despite the device’s non-invasive nature, the team had to pause and reconfigure their EU evidence strategy. 

2. Timelines and Review Unpredictability

The FDA, while not immune to complexity, generally provides more predictable timelines, especially when early interaction tools like Q-Subs are used. This helps companies plan launches and align with investors or partners. 

Under the MDR, review timelines can vary significantly between Notified Bodies. While conformity assessments follow defined procedures, delays are common, and often without clear communication. In one recent project, an EU submission based on an already-cleared US device took nearly a year to complete due to staggered feedback rounds and internal reviewer changes. 

These uncertainties make it difficult for SMEs to plan product launches, maintain investor confidence, or negotiate distribution deals. 

3. Classification Logic and Definitions

Device classification mismatches are another recurring challenge. A product considered Class II in the US may be classified as Class IIb or even Class III under the MDR, depending on its intended use or mode of action, particularly if it delivers energy into the body (e.g. electrical, thermal, or electromagnetic), which can trigger a higher classification under MDR Annex VIII. 

This difference is not simply cosmetic – it alters the entire regulatory approach, from required documentation to testing and audit requirements. In more than one project, I’ve had to help companies completely revise their classification rationale when transitioning from FDA to MDR, even when the product itself had not changed. 

What SMEs Can Do – and Where Consultants Help

Despite these challenges, there are ways to reduce complexity and avoid duplicated effort. The key is to plan early, stay realistic, and build a regulatory strategy that accounts for divergence rather than assuming equivalence. 

Three ways to streamline dual MDR/FDA submissions: 

• Map shared evidence early: Design bench tests, usability studies, and risk assessments with both regulators in mind.
• Leverage FDA Q-Sub feedback: Use insights from US reviewers to inform the structure of Clinical Evaluation Plans and PMS strategies for MDR.
• Clarify classification early on: Don’t assume US and EU definitions align – revisit Annex VIII of the MDR alongside FDA device classifications.

Consultants with experience across both systems can help SMEs identify overlaps, avoid blind spots, and develop documentation that supports parallel submissions without starting from scratch. 

What Needs to Change

While companies must adapt to the current landscape, there is scope for improvement at the system level. 

A few ideas that could reduce the burden without compromising safety: 

• Phased conformity or conditional approvals for low-risk, high-need devices – similar to models used in pharma.
• Increased acceptance of real-world evidence and legacy literature as part of PMCF and clinical evaluation.
• Structured EU–US dialogue to create informal or formal guidance on mutual expectations for testing, cybersecurity, and usability validation.

Of course these steps would not eliminate all divergence, but even modest alignment would make it significantly easier for SMEs to operate across both markets. 

Closing

Most startups I work with are trying to do the right thing. They want to comply. But they also want to survive. 

While the widening divergence between MDR and FDA systems is at its core a regulatory issue, it’s also an operational and strategic barrier that can affect investment, hiring, and time to market. 

With careful planning and the right kind of support, these challenges can be managed. By encouraging more transparency, dialogue, and flexibility in regulatory systems, we can ensure the path to market remains open – not only for large corporations, but also for the small teams building the future of healthcare technology.

References

• MDR Article 61, Annex XIV, Annex VIII 
• FDA 21 CFR 807 Subpart E (510(k)) 
• MDCG 2020-6: Clinical Evidence Needed for Medical Devices 
• ISO 14971:2019 Risk Management 
• MEDDEV 2.7/1 rev. 4 (legacy reference)

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