Is the UK really faster for lower-class software?

In short: The UK never adopted an equivalent to EU MDR Rule 11, so standalone software that needs Notified Body review in the EU can frequently still qualify for Class I self-certification in Great Britain. That is faster and cheaper, and it is not obligation-free: you still need a compliant technical file, a UK Responsible Person, MHRA registration, and post-market surveillance under the PMS Regulations 2024.

The arbitrage, and why it's real

Under UK MDR 2002 (as amended), the UK never adopted a direct equivalent to EU MDR's Rule 11, which is the specific rule that pushes most software with clinical decision-support functionality into Class IIa or higher in the EU. The practical result: standalone software that requires Notified Body review to launch in the EU can, under the UK's current rules, frequently still qualify for Class I self-certification in Great Britain — a materially faster and cheaper first launch, with no third-party conformity assessment required before market entry. "No Notified Body" is not "no obligations", though: self-certification still requires a compliant technical file, a UK Responsible Person, and MHRA registration. And note that CE marking remains accepted in Great Britain on a transitional basis, so depending on your sequencing you may not need the UKCA route immediately.

What this means for how you plan

Plan around genuine uncertainty rather than a false deadline. The arbitrage is real and usable today, and a reform process capable of eventually closing it is genuinely underway — one piece is already in force: the Medical Devices (Post-market Surveillance) Regulations 2024 have applied to all GB devices, including self-certified Class I software, since 16 June 2025, so the fast route already carries statutory post-market duties. What remains uncertain is the pre-market side: neither this page nor anyone else can currently give you a reliable date by which the Class I classification itself changes, and a plan built on "it definitely closes around mid-2027" is now known to be wrong. Use the UK route for what it's good at regardless: generating real-world use and revenue fast while you build toward EU or US certification in parallel. Check the MHRA's regulatory process directly if this arbitrage is load-bearing for your sequencing decision, rather than relying on a fixed date from any single source, including this one.

Where next: Where to Launch First: EU, UK, or US? · Where should I launch first: EU, UK, or US?

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