Where should I launch first: EU, UK, or US?

In short: It depends on your class in each system, not on market size alone. Standalone software that is Class IIa under EU MDR can, for now, remain self-certified Class I in the UK under the legacy framework — a faster first launch — while US timing hinges on predicate availability. Sequence by class, evidence, and revenue.

Status as of 2 July 2026: the UK arbitrage below is under a live MHRA reform process, but its actual closing date is currently unknown — see Is the UK really faster for lower-class software? before treating it as a stable long-term strategy.

The question underneath "which market first"

Market size is the wrong first filter — classification is. The same software can face a Notified Body queue in one system and self-certification in another, purely because of how each system's rules are structured, and that gap can be worth months of launch-timeline difference regardless of which market is commercially bigger for you. Before comparing markets on any other dimension, run your classification logic against each system separately rather than assuming your EU class automatically tells you your UK or US position.

The three-system snapshot

Under EU MDR, Rule 11 pushes most clinical decision-support software to Class IIa or higher, requiring Notified Body review. Under the UK's current legacy framework (UK MDR 2002, as amended), the same software frequently remains Class I, self-certified — a genuine, currently-exploitable divergence, under a live reform process whose actual closing date isn't yet known (see below). Two UK caveats: CE marking remains accepted in Great Britain transitionally, so an EU-first team may not need the UKCA route at all yet; and even self-certified Class I devices carry statutory post-market surveillance duties under the PMS Regulations 2024, in force since 16 June 2025 — a fast launch is not obligation-free. Under FDA, timing hinges less on class and more on predicate availability: a well-matched predicate can move a 510(k) through review in months, while a novel device with no predicate faces a longer route regardless of how it would classify elsewhere — De Novo (which FDA grants, rather than clears) for low-to-moderate-risk novel devices, or PMA for genuinely high-risk ones.

How founders actually sequence this

Evidence-thin, early-stage teams often benefit most from the fastest self-certifiable route to get real market feedback before committing to a Notified Body timeline. Teams with a strong predicate story lean toward an early US filing, since predicate fit — not overall market readiness — is what determines US speed. EU-core teams building toward Class IIb or III from the outset often sequence the EU first regardless of speed, since that's where the heaviest evidence-building work has to happen either way.

Where next: Where to Launch First: EU, UK, or US? · Is the UK really faster for lower-class software?

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