Quick Answer: There's no universal right answer, but the deciding factors are consistent. The real-world timeline gap is now dramatic: FDA's average total time to a 510(k) decision has run close to four months in recent fiscal years, while the European Commission's own survey of notified bodies found that under half of MDR certificates are issued within 13 to 18 months of application, and busy notified bodies run separate 6-to-12-month queues just to accept an application before that clock starts. FDA's fees are fixed and published; notified body pricing is commercially negotiated and historically opaque. A new EU regulation aims to standardize notified body timelines, but it doesn't take effect until 25 February 2027, so it offers no relief to a decision made today. If your actual goal is market access beyond the US or EU, FDA clearance is currently the more portable credential, since most third-country reliance frameworks are built around it. Manufacturers who need both markets eventually should build one shared evidence package and let the specifics decide which submission goes in first.
The real timeline gap
This is the fact that should drive most sequencing decisions, and it's worth being precise about where the numbers come from.
FDA's MDUFA V performance goal commits to a decision within 90 FDA days for 95% of 510(k) submissions. "FDA days" pause whenever the agency is waiting on you, so the more useful number for planning is the real, all-in average: FDA's own reporting shows average total time to decision, in calendar days, running around 112 to 128 days across recent fiscal years. Call it three and a half to four months for a typical submission that doesn't hit major complications.
The EU side looks very different in practice. The European Commission's 18th Notified Body Survey, covering data through March 2026, found that only 48% of MDR certificates are issued within 13 to 18 months of application. That's the review period alone, once a notified body has accepted your file. Before that, intake queues at the most in-demand bodies — BSI, TÜV SÜD, TÜV Rheinland, DEKRA — commonly run another 6 to 12 months before formal review even begins, according to industry tracking of current notified body capacity. Add the two together and a realistic total, from first contact to certificate in hand, runs 12 to 30 months depending on device class, with Class IIb and III devices at the longer end.
That gap — roughly four months versus somewhere between one and two and a half years — is the single most decision-relevant fact in this comparison, and it applies however sophisticated or well-resourced your regulatory team is. It's a structural feature of a notified body system with roughly 51 designated bodies serving an industry of more than 38,000 companies, not a solvable process problem on your end.
A real EU reform exists, and it doesn't help you yet
On 4 May 2026, the European Commission adopted Implementing Regulation (EU) 2026/977, published in the Official Journal the following day. It sets uniform quality management and procedural requirements for notified bodies, including standardized quotations with clear cost breakdowns and defined maximum timelines for stages of conformity assessment, specifically to address the inconsistent, opaque practices that have made notified body timelines so hard to plan around.
Read the effective date before adjusting any near-term plan around it: the regulation applies from 25 February 2027, with its annual reporting requirements not kicking in until 1 January 2028. It says nothing about the pre-application intake queues that currently add months before review even starts. If you're deciding between FDA and CE Mark today, or over the next twelve to eighteen months, this reform is a reason for cautious optimism about 2027 and beyond. It changes nothing about the timeline you'd actually face if you submitted this quarter.
This sits alongside the broader MDR simplification proposal, COM(2025) 1023, which we've covered separately: that package is also not law yet, and isn't expected to be adopted before 2027 either. Plan against the system as it operates today, not the one that's been proposed.
Cost: fixed and published versus negotiated and historically opaque
FDA's fees are the same for every applicant and published a year in advance. In FY2027, a standard 510(k) is $28,653, or $7,163 with small business status, plus $13,785 for annual establishment registration.
Notified body fees don't work that way. Pricing is commercially negotiated, has historically varied by body without a required standard format, and Implementing Regulation 2026/977 exists specifically because some notified bodies gave detailed upfront quotations and others didn't. That inconsistency is real today and, per the regulation's own effective date, will remain so until 2027.
If your real goal is a third market, FDA is currently the more portable asset
This is worth stating plainly if it's not already your framing: for many manufacturers, neither the US nor the EU is actually the end goal. The real prize is Latin America, the Gulf, ASEAN, or India, and FDA or CE Mark is the credential that unlocks faster entry there. On that basis, the two aren't equivalent right now.
WHO's July 2026 list of transitional Listed Authorities names FDA. The EU's Notified Body network is also represented, so this specific list doesn't favor one over the other. But look at what's happened at the country level: Malaysia's Verification Route names FDA as one of eight recognized reference authorities, and the US-Malaysia and US-Taiwan trade agreements signed in the past year both specifically extract commitments to recognize FDA decisions. CE Mark and EU Notified Bodies show up in some of these frameworks too, but FDA is the one appearing consistently across nearly every reliance mechanism we've reviewed this year, likely because a single US federal agency is a simpler thing for another country to name in a bilateral agreement than a network of more than fifty independent commercial notified bodies. If third-country reliance is genuinely your strategic objective, that pattern is worth weighing on its own, independent of the raw timeline difference.
What transfers either way, and what doesn't
Regardless of which one you file first, the underlying test data is often reusable. Biocompatibility testing to the ISO 10993 series, electrical safety and EMC testing to IEC 60601, and software lifecycle documentation under IEC 62304 are generally not regime-specific if performed to a current, recognized standard version on your finished device. What actually transfers from a CE Mark file to a 510(k) covers this in detail, and the logic runs the same direction either way: build the evidence once, to the more rigorous standard version where the two differ, and both submissions draw from it.
What doesn't transfer is the regulatory argument itself. FDA requires substantial equivalence to a US-marketed predicate. The EU requires conformity with the General Safety and Performance Requirements and a risk-benefit determination against your own device, not a comparator. Whichever pathway you pursue first, the argument has to be built fresh for the second one.
The parallel-path option most well-resourced companies actually use
Framing this as a strict either-or undersells how larger manufacturers actually approach it. The more common pattern among companies with the resources to run it is a single shared evidence-generation program — one round of biocompatibility, electrical safety, and software testing built to satisfy both regimes' strictest requirements — with submission timing decided separately for each market based on its own specifics: predicate availability for FDA, notified body queue position for CE Mark.
Run this way, "which one first" becomes a question about which submission is ready to file first, not a strategic commitment that locks out the other market. If your predicate situation at FDA is unclear, that's worth resolving early regardless of which submission you expect to file first, since it determines your realistic FDA timeline more than anything else does.
When CE Mark first genuinely makes sense
The timeline and reliance arguments favor FDA for many manufacturers, but not all of them, and the honest exceptions are worth naming.
If you already have EU distribution commitments tied to a specific launch date, that constraint may simply outweigh the general timeline argument. If your device's predicate landscape at FDA is genuinely thin, because it was built for markets with different typical device designs, a CE Mark route with an established EU product category may be the more achievable near-term win, even with the longer notified body timeline. And if you already hold a strong relationship with a notified body that isn't capacity-constrained for your device class, the 12-to-30-month range narrows toward its lower end, which changes the calculus.
Common mistakes
Assuming CE Mark is faster because it used to be. Under the old Medical Devices Directive, EU market entry was often faster than FDA. Under MDR, that has reversed, and the gap is now large.
Planning around the 2026/977 reform as if it's already in effect. It doesn't apply until 25 February 2027. Submissions filed before then face the current, unreformed timeline.
Treating "which one first" as a permanent commitment. Evidence built for one regime is often reusable for the other. The sequencing decision is about submission timing, not exclusive strategic direction.
Ignoring the intake queue when estimating EU timelines. The often-cited 13-to-18-month figure is review time alone, after a notified body accepts your application. Add the queue to get a realistic total.
Picking a notified body without confirming its current capacity. Some bodies report no capacity restrictions; others are running 6-to-12-month intake queues. This is now a strategic variable, not an administrative detail.
Frequently asked questions
Should I get FDA clearance or CE Mark first? For most manufacturers, FDA is now the faster and cheaper route to a first clearance, and it's increasingly the credential other countries' reliance frameworks are built around. Exceptions exist for manufacturers with immediate EU distribution commitments, a thin US predicate landscape for their specific device, or an existing relationship with an uncapacitated notified body.
How much longer does CE Mark take than FDA clearance in 2026? Substantially longer. FDA's real average time to a 510(k) decision runs three and a half to four months. The European Commission's own notified body survey found fewer than half of MDR certificates issued within 13 to 18 months, and that excludes the 6-to-12-month intake queues common at busy notified bodies.
Has the EU fixed its notified body timeline problem? Not yet in practice. Implementing Regulation (EU) 2026/977 sets standardized requirements for notified body timelines and quotations, but it doesn't apply until 25 February 2027. Submissions filed before that date face the current, longer timelines.
Is it cheaper to get FDA clearance or CE Mark first? FDA's fees are fixed and published a year in advance: $28,653 for a standard 510(k) in FY2027, or $7,163 with small business status. Notified body fees are commercially negotiated and have historically varied in transparency between bodies, which is part of what the 2026/977 reform is meant to address once it takes effect.
Does FDA clearance help me in other countries more than CE Mark does? Currently, often yes. FDA appears consistently across recent third-country reliance mechanisms, including Malaysia's Verification Route and the 2025–2026 US trade agreements with Malaysia and Taiwan, which specifically extract commitments to recognize FDA decisions. CE Mark and EU notified bodies appear in some frameworks too, but less consistently across the markets we've reviewed.
Can I use the same testing for both FDA and CE Mark? Often, yes. Biocompatibility, electrical safety, and software lifecycle testing performed to current, recognized standard versions on your finished device are generally reusable across both regimes. The regulatory argument itself — substantial equivalence for FDA, conformity with the General Safety and Performance Requirements for the EU — has to be built separately for each.
Should I pursue FDA and CE Mark at the same time instead of choosing one first? Many well-resourced manufacturers do exactly this: build one shared evidence package, then let each submission's own specifics, predicate availability for FDA, notified body queue position for CE Mark, determine which one actually files first.
Is the EU MDR reform going to make CE Mark faster than FDA again? Not in the near term. Even if the broader simplification proposal and the notified body timeline regulation both proceed as planned, full effect isn't expected before 2027, and backlogs built up over prior years won't clear immediately once new rules apply.
What's the biggest planning mistake manufacturers make with EU timelines? Quoting the 13-to-18-month notified body review figure as the whole timeline. It's the review stage alone, after acceptance. Realistic total time, including the intake queue at a busy notified body, runs 12 to 30 months depending on device class.
Does device classification affect which market I should pursue first? It affects the EU timeline more than the FDA one. Class IIa devices under MDR typically see shorter notified body timelines than Class IIb or III. FDA's 510(k) timeline is less sensitive to device class specifically and more sensitive to predicate clarity.
Key takeaways
The timeline gap is now large and well-documented. FDA's real average is under four months. The EU's own survey shows under half of MDR certificates issued within 13 to 18 months, before counting intake queues.
The EU's own reform doesn't apply until 2027. Plan against the system as it currently operates, not the one that's been adopted but isn't yet in effect.
FDA is the more consistently portable credential right now, if third-country access is the real goal. It appears across more current reliance frameworks than CE Mark does, in the markets we've reviewed this year.
Evidence is reusable; the regulatory argument isn't. Build testing once, to the stricter applicable standard, and expect to construct the substantial equivalence or GSPR argument separately for each regime.
It doesn't have to be strictly sequential. Larger manufacturers commonly build one evidence package and let each market's own specifics decide submission timing.
Complizen helps international medical device manufacturers reach FDA 510(k) clearance, combining a software platform for in-house regulatory teams with full-service consultancy for teams without in-house FDA expertise.
Deciding which market to pursue first is a strategy question best answered against your specific device, predicate landscape, and target markets, not a general rule. Complizen's regulatory strategy engagement maps your device to a pathway and sequencing plan, reviewed by a senior FDA expert. See how the strategy service works →
References
- FDA — MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027. https://www.fda.gov/media/73507/download
- Federal Register — Medical Device User Fee Rates for Fiscal Year 2027. https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027
- Arnold & Porter — The EU Medical Device Shake-Up: What International Companies Should Prepare For (secondary source; legal analysis, citing the EU's stakeholder feedback timeline). https://www.arnoldporter.com/en/perspectives/advisories/2026/02/the-eu-medical-device-shake-up
- EUCertify — Notified Body Availability & Capacity Tracker 2026, citing the European Commission's 18th Notified Body Survey (secondary source; industry tracker). https://eucertify.com/notified-body-availability/
- MedStrato — EU MDR Notified Body List 2026: All Designated NBs + Selection Guide (secondary source; regulatory consultancy). https://medstrato.com/blog/eu-mdr-notified-body-list-2026
- AESGP — Statement on Commission Implementing Regulation (EU) 2026/977 Setting Maximum Timelines for Conformity Assessment Activities of Medical Devices. https://aesgp.eu/articles/aesgp-statement-on-commission-implementing-regulation-eu-2026-977-setting-maximum-timelines-for-conformity-assessment-activities-of-medical-devices
- Saraca Solutions (via OpenPR) — Regulation (EU) 2026/977 Introduces New Requirements for Notified Bodies, confirming the 25 February 2027 application date (secondary source, citing official text). https://www.openpr.com/news/4539433/regulation-eu-2026-977-introduces-new-requirements
- European Commission — Medical Devices: New Regulations, listing Implementing Regulation (EU) 2026/977. https://health.ec.europa.eu/medical-devices-new-regulations_en
- European Commission — Proposal for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746, COM(2025) 1023 final. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52025PC1023
- WHO — List of transitional WHO Listed Authorities for medical devices (tWLAs-MD), as of 1 July 2026 (PDF). https://cdn.who.int/media/docs/default-source/medicines/regulatory-systems/wla/list-of-transitional-wlas_md.pdf