Manufacturers deciding which market to take first usually compare the cost of each route in isolation. That misses the part that changes the answer: several regulators outside the Union treat European conformity assessment as evidence, and one of them asks for more than the certificate.
This is orientation for sequencing decisions, not a substitute for the current requirements of each authority.
| Market | How European evidence is treated | What it does not remove |
|---|---|---|
| Great Britain | CE marked devices accepted under transitional arrangements running to 30 June 2028 and 30 June 2030, with a 2026 consultation on open-ended recognition | A UK Responsible Person and UK registration |
| Switzerland | Legislation mirrors the MDR, and European conformity assessment underpins the domestic route | A Swiss representative for devices entering Switzerland |
| Australia | Certificates from EU notified bodies accepted as comparable overseas evidence; overseas reports can abridge a TGA conformity assessment | An Australian sponsor and inclusion in the register |
| Singapore | European approval counts as a reference agency approval, opening abridged and faster routes | A local registrant and the national application |
| Israel | Recognition route relies on approval in a recognised jurisdiction | The device must also be legally placed on the market in a Member State |
| Türkiye | National rules mirror the MDR and IVDR, so the technical work is largely common | Registration in the national tracking system before supply |
| Ukraine | European conformity assessment results continue to be recognised under the current framework | The reverse does not apply; Ukrainian certificates do not open the Union |
A company that certifies for a small market first often finds that the work has to be redone for Europe, because the European file is the more demanding one and the more widely recognised. A company that starts in Europe frequently finds that the same file, and sometimes the same certificate, shortens three or four later applications.
That is not an argument for always going to Europe first. It is an argument for deciding the order deliberately, with the recognition rules of the target markets on the table, rather than following whichever distributor called first.
Recognition of an approval and recognition of a certificate are not the same thing. The Israeli route is the clearest example: the reviewer looks for a device that is approved and legally placed on the market in the recognised jurisdiction, so a certificate obtained for a tender and never used to supply a device does not carry it.
This is where the European economic operators matter beyond compliance. A first placing on the market needs an importer that meets its own obligations, a label carrying the representative and importer details, and a registration that shows the device in EUDAMED. Those are the facts a foreign reviewer can verify.
No. Every market in the table keeps its own local role, whether that is a sponsor, a registrant, an importer or a responsible person. Recognition applies to evidence, not to legal presence.
Often, in direct cost. The comparison worth making is total cost across the markets actually planned for the next three years, including work that would have to be repeated.
Less, because there is no notified body certificate to present. The declaration of conformity, the technical documentation and the registration still form a file that other authorities can read.
Recognition rules change, and two of the entries were amended in 2026. Confirm the position with the target authority before committing a launch plan to it.
Each market below was checked against the position published by its own regulator or in its official legal register. The MDR obligations were checked against the EUR-Lex text.
Regulation (EU) 2017/745 (MDR) in EUR-Lex → · MHRA: regulating medical devices in the UK →Review the service scope for manufacturers established outside the Union, or start with the market entry hub to see the route end to end.
