“Novel” or “better” medical devices: How reimbursement differs across the EU and US

What’s the difference?

Novel devices often require new reimbursement codes and supporting evidence, which can make timelines longer and less predictable. In many cases, even the basic clinical foundations, such as the way a disease is defined or treated, must be reviewed and validated during the HTA process.

“Better” devices, on the other hand, fit more easily into existing reimbursement pathways, allowing them to secure coverage much faster, sometimes within a few months in Europe or 6–18 months in the US.

So, regulatory approval gets you to market, but market access planning gets you to patients, and starting early can make all the difference.

The following questions form the cornerstone reimbursement path when you have just begun developing a medical device or have just applied for regulatory clearance and you know it will be used by clinicians to treat or diagnose diseases:

1. Does the device fit into an existing reimbursement pathway or does it require a new one?

• For novel devices, manufacturers must often create new coding, tariffs, or coverage pathways (e.g., new CPT/HCPCS/APC in the US, new DRG/add‑on or NUB‑style classifications in the EU).

• For “better” devices, the focus is usually on fitting into existing codes or tariffs by demonstrating clear comparability or incremental benefit over the incumbent technology, making the reimbursement pathway more straightforward but still evidence‑intensive.

  
  

2. How early and how formally should you engage with HTA bodies and payers in each region?

• In the EU, novel devices typically require structured or informal dialogues with national HTA/payer agencies (e.g., G‑BA, HAS, AIFA, NICE) early in development to shape evidence and pricing expectations; “better” devices can still leverage these early dialogues but may anchor to existing HTA references.

• In the US, tools like FDA Early Payor Feedback and FDA–CMS Parallel Review help both novel and “better” devices align trial design with payer needs, but the urgency is higher for novel devices that lack any established coverage precedent.

  
  

3. What evidence is needed to show value for a novel versus a “better” device?

• Novel devices must demonstrate not only safety and efficacy but also clinical necessity and economic sustainability, often including budget‑impact analyses and health‑economic models from the outset, since they lack a comparator.

• “Better” devices must prove superior outcomes, cost‑effectiveness, or workflow advantages versus the current standard, with HTA bodies in the EU demanding incremental benefit assessments and US payers increasingly asking for real‑world and outcomes‑based evidence.

  
  

4. How does the reimbursement application process differ between entirely new devices and those that improve on existing technologies?

• For novel devices, the EU pathway often involves a dedicated HTA and reimbursement dossier that may even require a new code or tariff tier, while the US route may involve new or modified CPT/HCPCS codes, coverage with evidence development (CED), or local coverage determinations.

• For “better” devices, the EU submission can often reference existing HTA decisions and may only need a dossier showing incremental benefit, whereas in the US the focus is on formulary updates or coverage policy changes rather than full‑scale new‑code creation.

  
  

5. What are the implications for time to coverage, pricing, and investor due diligence?

• Novel devices face longer approval‑to‑coverage timelines in both the EU and the US, with higher reimbursement risk and more complex pricing and contracting strategies (e.g., outcomes‑based agreements, temporary or pilot‑based coverage).

• “Better” devices generally achieve faster reimbursement uptake because they piggyback on existing codes and coverage; however, investors and acquirers will still scrutinize local HTA scores, coverage stability, and the risk of displacement by the next generation of technology.

  
  

6. How long does it take to secure reimbursement after regulatory approval in the EU and US, and why does it differ for novel vs “better” devices?

Regulatory approval shows your device is safe; reimbursement proves it’s valuable enough for payers to cover, and that often takes much longer.

After CE marking, novel or high‑risk devices may undergo detailed HTA reviews, taking anywhere from 4 months in Germany (if an existing code applies) to over two years where new tariffs or evidence are needed.

In the US, getting FDA clearance might be faster, but coverage can lag. When a device needs a new billing code or Medicare pathway, the process can stretch 18–24 months, and for some technologies, studies show up to five years before full coverage.

In conclusion: In medtech environment, having a groundbreaking idea is just the beginning. Even the most advanced device can struggle to reach patients if there isn’t a clear market access and reimbursement plan behind it. For startups, thinking about health economics and payer needs early isn’t extra work but it’s a vital part of making innovation pay off.

The reality is simple: payers fund value, not technology. Building a strong case for real‑world impact through smart evidence generation, early coding strategy, and well‑structured health economic demos can make the difference between market success and years of frustration.

Too often, promising startups focus only on engineering and clinical milestones, leaving access planning for later. But waiting until after regulatory approval can lead to painful delays. Imagine perfecting your product, only to discover it lacks a reimbursement pathway, meaning physicians can’t bill for it and patients can’t access it.

The startups that win are those that plan for coverage from day one. They build payer expectations into their development strategy, collect the right data early, and speak the language of value. At Stepval, we’ve seen these companies move faster, gain payer trust, and deliver real outcomes faster, and of course that depends on the priority objectives of each team.

In short: a great device opens possibilities, but a great pipeline access strategy opens markets.

In today’s fast‑moving medtech world and digital health, early market access planning isn’t a nice‑to‑have anymore, rather it’s a must‑have.