The EU and the US together represent more than 60% of the global medical device market. For a MedTech startup with ambitions beyond a single geography, accessing both markets is not a luxury — it is the path to building a viable, fundable, scalable company.
But "targeting both markets simultaneously" does not mean doing everything twice in parallel from day one. It means building a regulatory strategy that serves both markets efficiently, leveraging overlaps where they exist and managing differences where they diverge.
This post provides the strategic framework.
The Strategic Question: Sequence or Parallel?
The first decision is whether to pursue EU and US market access sequentially or in parallel.
Sequential (One Market First, Then the Other)
EU first, then US: Build MDR compliance. Get CE marked. Use the EU technical documentation, clinical evidence, and QMS as the foundation for the FDA submission.
This is the approach Tibor recommends for most startups: "MDR is the more demanding framework. Build for MDR, and your FDA submission will be easier. Build for FDA first, and you will find significant gaps when you turn to MDR."
The advantages are real: - MDR clinical evidence typically exceeds FDA 510(k) requirements - ISO 13485-based QMS serves both markets (with the FDA's QMSR transition) - MDR technical documentation is comprehensive and translates well to FDA format - Focused execution — one regulatory project at a time - Revenue from the EU market funds US market entry
US first, then EU: Less common for EU-based startups, but relevant if your primary market or lead customer is in the US. The 510(k) pathway can be faster for Class II devices (6-12 months from submission to clearance), giving you earlier market entry and revenue.
The disadvantage: FDA documentation alone does not meet MDR requirements. Significant additional work is needed for MDR — particularly clinical evaluation per Article 61, post-market surveillance per MDR's more demanding requirements, and documentation per Annex II format.
Parallel (Both Simultaneously)
Pursuing both CE marking and FDA clearance/approval simultaneously. This is feasible but resource-intensive. It makes sense when: - Investor pressure or business strategy demands rapid access to both markets - Your team has sufficient regulatory bandwidth (or budget for external support) to manage two parallel processes - Your device classification and evidence requirements are similar in both jurisdictions
Building the Dual-Market Foundation
Regardless of whether you sequence or parallelize, certain elements should be built as shared infrastructure from day one:
1. Quality Management System
The overlap is almost complete. ISO 13485 is recognized in both the EU (harmonized under MDR) and the US (basis for the new QMSR). Build one ISO 13485-certified QMS and it serves both markets.
Minor adaptations may be needed: - US-specific requirements under 21 CFR Part 820 (until fully replaced by QMSR) may include specific provisions not covered by ISO 13485 - Documentation of design controls must be particularly robust — the FDA emphasizes design control heavily - Your QMS must accommodate dual vigilance reporting (to EU competent authorities and to the FDA)
Startup tactic: Implement ISO 13485 from day one with both markets in mind. The incremental cost of designing the QMS for dual jurisdiction is minimal compared to retrofitting later.
2. Design and Development Documentation
Design history files, design inputs, design outputs, verification, and validation — these are required by both MDR and FDA. The FDA's design control requirements (21 CFR 820.30) and MDR's design and development requirements are structurally similar.
Build your design documentation once, with enough detail to serve both jurisdictions. Key elements: - Clear design inputs traceable to both EU GSPRs and FDA performance requirements - Comprehensive design verification and validation - Design reviews documented at key milestones - Design transfer documentation - Design change control
3. Risk Management
ISO 14971 is the risk management standard recognized by both the EU and the US. One risk management file serves both markets. Ensure your risk management addresses hazards and risks relevant to both jurisdictions.
4. Core Testing and Verification
Most bench testing, biocompatibility testing, electrical safety testing, and software verification is jurisdiction-agnostic. Test reports generated for MDR compliance are accepted by the FDA, and vice versa, as long as they are performed to recognized standards.
Where testing diverges: The FDA may accept different standard editions or recognize different performance benchmarks. In some cases, US-specific testing (e.g., specific FDA guidance documents) may be needed in addition to EU harmonized standard testing.
Startup tactic: When planning your testing program, identify the complete set of tests needed for both markets. Run them as a single program where possible, adding jurisdiction-specific tests where required. This is far more efficient than running separate test campaigns for each market.
Where the Strategies Diverge
Clinical Evidence
This is the biggest divergence and the area requiring the most strategic attention.
For the EU: MDR requires clinical evidence for all devices. Your clinical evaluation must follow MDCG guidance, include a systematic literature review, and for higher-risk devices, may require clinical investigation data. The CER is a comprehensive document.
For the US: The 510(k) pathway requires demonstration of substantial equivalence to a predicate device. Clinical data may or may not be required. For PMA, clinical investigation data is typically needed.
Dual-market clinical strategy:
If your device needs a clinical investigation for MDR, that investigation can often be designed to serve both markets: - Design the study to meet both EU clinical investigation requirements (Annex XV, ISO 14155) and FDA clinical investigation requirements (21 CFR Part 812) - Consider conducting the study at sites in both the EU and the US - Ensure the study endpoints satisfy both MDR clinical evaluation requirements and FDA safety/effectiveness standards - File the study under both jurisdictions simultaneously (MDR via Member State competent authority notification; FDA via IDE — Investigational Device Exemption)
If your device can proceed via literature-based clinical evaluation for MDR and a 510(k) with bench data for the FDA, the two pathways can proceed independently with shared underlying technical data.
Regulatory Submissions
The submission formats differ completely:
EU: Technical documentation per Annex II, reviewed by the Notified Body. No standardized submission format — each NB has its own preferences, but the content requirements are defined by MDR.
US (510(k)): A specific submission format defined by the FDA, including device description, substantial equivalence comparison, performance data, and biocompatibility summary. The format follows FDA guidance documents.
US (PMA): A comprehensive submission format with extensive clinical data, manufacturing information, and labeling.
You cannot submit the same document to both jurisdictions. But you can (and should) use the same underlying data. Build your technical documentation in a modular way — core data modules (test reports, risk management file, clinical data) that can be assembled into either an EU technical file or a US submission.
Labeling
EU labeling requires multi-language translations, MDR Annex I Chapter III format, UDI per EUDAMED requirements, and the CE mark.
US labeling requires English language, 21 CFR Part 801 format, UDI per GUDID requirements, and no CE mark (but any relevant FDA clearance/approval information).
For physical products, this means either dual-labeled products (with both CE and FDA information) or separate label variants for each market. For software, separate regulatory information screens may be needed.
Post-Market Systems
Your post-market system must accommodate both jurisdictions: - Complaint handling that routes reports to both EU vigilance authorities and FDA MDR (Medical Device Reporting) - PMS activities that generate data for both EU PSURs/PMS reports and FDA post-market requirements - CAPA processes that document actions and effectiveness for both NB surveillance audits and potential FDA inspections
The Dual-Market Budget
Building for dual-market access increases total regulatory cost but less than doubling it, thanks to shared infrastructure:
| Category | EU Only | EU + US (Incremental for US) |
|---|---|---|
| QMS | EUR 20,000 - 80,000 | + EUR 5,000 - 15,000 (minor adaptations) |
| Testing | EUR 25,000 - 200,000 | + EUR 5,000 - 30,000 (US-specific tests) |
| Clinical evidence | EUR 15,000 - 500,000+ | + EUR 0 - 50,000 (clinical data typically reusable) |
| Regulatory documentation | EUR 40,000 - 150,000 | + EUR 30,000 - 100,000 (FDA submission preparation) |
| Notified Body / FDA fees | EUR 20,000 - 150,000 (NB) | + EUR 15,000 - 50,000 (FDA user fees for 510(k)) |
| Regulatory expertise | EUR 30,000 - 100,000 | + EUR 20,000 - 80,000 (US regulatory consultant) |
| US Agent | N/A | + EUR 3,000 - 10,000/year |
| Total | EUR 150,000 - 1,000,000+ | + EUR 80,000 - 335,000 |
The US incremental cost is roughly 30-50% on top of the EU regulatory investment for a 510(k) device. For PMA devices, the incremental cost is significantly higher due to the more extensive FDA review and potentially a US-based clinical investigation.
The Timeline for Dual Markets
Sequential (EU First)
| Phase | Timeline |
|---|---|
| EU CE marking (Class IIa example) | Month 1-18 |
| EU market entry | Month 18 |
| US 510(k) preparation (leveraging EU documentation) | Month 12-21 (can start before CE marking complete) |
| FDA 510(k) submission | Month 21 |
| FDA review | Month 21-27 |
| US market entry | Month 27 |
Total time to both markets: approximately 27 months.
Parallel
| Phase | Timeline |
|---|---|
| Shared QMS, testing, clinical evidence | Month 1-12 |
| EU NB engagement and review | Month 6-18 |
| FDA 510(k) preparation and submission | Month 10-16 |
| EU CE marking | Month 18 |
| FDA clearance | Month 16-22 |
| Both markets | Month 18-22 |
Total time to both markets: approximately 18-22 months (faster, but more resource-intensive).
Investor Considerations
Investors in MedTech startups care about market access — it directly drives revenue potential and company valuation. Having a clear dual-market regulatory strategy is a significant advantage in fundraising:
- Seed/Pre-Seed: Show that you understand both regulatory pathways and have a clear strategy for sequencing
- Series A: Ideally have CE marking in progress and a defined FDA strategy with timeline and budget
- Series B: Both market authorizations in hand or imminent, demonstrating commercial readiness in both jurisdictions
Tibor's investor communication advice: "Investors want to hear two things about your regulatory strategy: that it is realistic and that it is capital-efficient. A dual-market plan that is honest about timelines and costs is far more compelling than a fantasy plan that claims both markets in 12 months. Show the sequence, show the budget, show the milestones."
Common Mistakes in Dual-Market Planning
Mistake 1: Building Separate Documentation from Scratch
Some companies build EU and US documentation independently, duplicating effort. Instead, build modular core documentation (test reports, risk management, clinical data) that feeds both submissions.
Mistake 2: Choosing EU or US Regulatory Format First Without Planning for the Other
If you format your documentation exclusively for the EU Notified Body, reformatting for an FDA submission later takes time. Plan for modularity from the start.
Mistake 3: Ignoring One Market Until Too Late
Startups that focus exclusively on one market and then "turn to" the other market late in their development often discover gaps that require significant rework. Even if you are sequencing, keep the second market in mind during the first market's preparation.
Mistake 4: Assuming Regulatory Experts Are Interchangeable
EU regulatory expertise does not equal US regulatory expertise. Engage specialists for each jurisdiction. A generalist who claims competence in both is likely strong in one and weak in the other.
Mistake 5: Underestimating FDA User Fees
FDA user fees for 510(k) submissions and establishment registrations are real costs that some EU startups overlook. Check the current fee schedule and budget accordingly.
The Bottom Line
Targeting both the EU and US markets is a sound strategic ambition for most MedTech startups. The key is building a regulatory strategy that maximizes synergies between the two systems while respecting their differences.
Build your QMS once (ISO 13485). Build your core documentation once (modular). Generate your evidence once (designed for both markets). Then adapt the outputs for each jurisdiction's specific submission requirements.
Sequence EU first for most startups — MDR is the harder exam, and passing it gives you a strong foundation for the FDA. Parallelize if your resources and market timing demand it.
And above all, engage jurisdiction-specific expertise for each market. The similarities between MDR and FDA are substantial, but the differences are where mistakes happen.
Two markets, one foundation, two submissions. Build smart, sequence wisely, and your company gains access to the majority of the global medical device market.