One market became two, and the second is still being written

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.

Around 600 million people, and one conformity assessment that opens most of them — but "most" is doing real work in that sentence. The CE mark is the entry ticket to the EU's twenty-seven member states; on top of it sit national layers that decide whether you can actually sell, and several member states run their own catalogues and language rules regardless of the mark you hold.

The UK is now a separate decision. It runs its own system, needs its own UK Responsible Person, and — unlike the EU — treats prior approvals as a shortcut rather than starting from scratch. That makes the order between them a genuine lever, which it never used to be.

In both, you own the certification and you still need someone local. A non-EU manufacturer must appoint an Authorised Representative, and a non-UK manufacturer a UK Responsible Person — these are legal requirements, not conveniences. The UKRP is the more involved of the two: your MHRA registration is made through them and their name and address appear on the label.

What differs from most of Asia is ownership, not whether a local party exists. The CE certificate and the UK conformity assessment are issued to you. Your representative acts for you and can be replaced; they do not hold the thing that lets you sell. That is the distinction worth carrying into a partner negotiation — in much of Asia, the approval is issued in your partner's name.