Europe used to be the simplest expansion decision a manufacturer made: one conformity route, one market, twenty-seven-odd countries. It is not that any more. The EU and UK now run separate systems, the UK's is still being finalised, and the practical question for a mid-sized manufacturer is no longer whether to go but which of the two to do first.
Request a demo →This trips up more expansion plans than any other feature of the region. For market authorisation, the EU behaves as a single market — a device cleared for it is cleared across the member states, and the individual countries hold no separate registrations of their own.
For actually selling, it is nothing of the kind. Reimbursement, procurement and purchasing are national and sometimes regional. Several member states also maintain their own national catalogues on top of the EU layer — Italy's runs to over a million entries — which are a genuine source of visibility into what is on the ground, and a genuine source of confusion for anyone reading record counts as market size.
Plan the authorisation once. Plan the route to revenue country by country.
The European technical file is the most demanding document set most manufacturers will ever assemble, and the notified body relationship is a long one that rewards being handled well from the start. Divergence has added a second question on top: what the UK route asks of you, and whether doing it first or second changes the work.
This is the other region where we tell people to buy judgement rather than software. We work with consultants covering the EU and UK and can introduce you — again, no fee and no arrangement, just someone we would use.
"Registered only here" is the share of a market's manufacturers who appear in none of the other 29 markets we cover — the closest single measure of how much of your competition is local. "Also holds US or EU" is the share who were approved in a major market too.
| Market | Product records | Manufacturers | Registered only here | Also holds US or EU |
|---|---|---|---|---|
| Italy | 1,030,210 | 12,996 | 29.6% | 59.5% |
| European Union | 428,894 | 39,526 | 57.6% | 0.0% |
| United Kingdom | 135,502 | 11,560 | 35.7% | 60.1% |
| Germany | 49,754 | 1,683 | 42.5% | 48.8% |
Figures from the Meridian Trace corpus, August 2026. Record counts are not market size — markets catalogue at different levels of detail, and a bigger number often means a more granular filing convention rather than a bigger opportunity. Company identity is resolved across scripts and spelling variants, which is a derived judgement rather than a registry fact.
Tell us the markets you are weighing and we will show you your own account with your products in it. If what you actually need is a consultant who works this region, we will introduce you to one — no fee, no arrangement on our side.