Who imports medical devices into the EU: the 2026 importer map.

By Bastion Hale · 23 October 2026 · Data: EUDAMED snapshot of 22 October 2026 · 5 minute read

EUDAMED actor registration has been mandatory since 28 May 2026. The public register now shows who imports devices into each European country. In 17 of 33 jurisdictions, importers outnumber manufacturers.

12,612importer registrations

17,284manufacturer registrations

17 of 33jurisdictions where importers outnumber manufacturers

1,990importers in Germany, the most of any country

The headline

Across the 33 jurisdictions in our pull, EUDAMED lists 12,612 active importer registrations and 17,284 manufacturer registrations. That is 0.73 importers for every manufacturer. It also lists 2,661 authorised representatives.

The total hides two different Europes. In the big manufacturing countries, makers outnumber importers. Germany has the most importers of any country, 1,990, but 3,606 manufacturers, a ratio of 0.55. Italy's ratio is 0.36.

In smaller and southern and eastern markets it flips. Importers outnumber manufacturers at least three to one in Cyprus (141 to 19), Malta (88 to 17), Slovenia (287 to 81) and Romania (673 to 208). Spain is the large market that breaks the pattern: 1,129 importers against 882 manufacturers.

Importers are also concentrated. The top five countries hold 5,948 of the 12,612 importer registrations, about 47 percent.

Top 15 countries by importer registrations

Importer registrations per country, EUDAMED actor module, snapshot of 22 October 2026. Table version below.

Top 15 countries by EUDAMED importer registrations, with manufacturer registrations and the ratio
Country	Importers	Manufacturers	Importers per manufacturer
1. Germany	1,990	3,606	0.55
2. Spain	1,129	882	1.28
3. Italy	1,070	2,999	0.36
4. France	896	1,891	0.47
5. Netherlands	863	1,120	0.77
6. Poland	809	857	0.94
7. Romania	673	208	3.24
8. Türkiye	639	1,162	0.55
9. Czechia	511	377	1.36
10. Greece	375	140	2.68
11. Hungary	368	276	1.33
12. Belgium	329	364	0.90
13. Portugal	295	257	1.15
14. Slovenia	287	81	3.54
15. Ireland	286	188	1.52

The ratio table, every jurisdiction

Sorted by importers per manufacturer, highest first. A ratio above 1 means the country lists more importers than manufacturers. Switzerland is left out of the ratio: it lists 578 manufacturers and no importers in this pull, because its coverage in EUDAMED depends on bilateral arrangements and is partial. Download the full table as CSV.

Importer, manufacturer and authorised representative registrations per jurisdiction, sorted by ratio
Jurisdiction	Importers	Manufacturers	Authorised reps	Ratio
Cyprus	141	19	12	7.42
Malta	88	17	11	5.18
Slovenia	287	81	12	3.54
Romania	673	208	46	3.24
Croatia	171	59	9	2.90
Greece	375	140	6	2.68
Bulgaria	148	57	4	2.60
Latvia	82	32	19	2.56
Slovakia	190	100	23	1.90
Lithuania	120	66	22	1.82
Iceland	23	13	1	1.77
Ireland	286	188	192	1.52
Czechia	511	377	52	1.36
Estonia	61	46	40	1.33
Hungary	368	276	46	1.33
Spain	1,129	882	199	1.28
Portugal	295	257	53	1.15
Northern Ireland	37	38	37	0.97
Poland	809	857	42	0.94
Belgium	329	364	75	0.90
Netherlands	863	1,120	351	0.77
Norway	114	150	7	0.76
Austria	220	310	52	0.71
Luxembourg	13	19	6	0.68
Finland	192	288	15	0.67
Germany	1,990	3,606	651	0.55
Türkiye	639	1,162	65	0.55
Denmark	211	410	47	0.51
France	896	1,891	244	0.47
Liechtenstein	9	19	11	0.47
Sweden	272	655	54	0.42
Italy	1,070	2,999	257	0.36
Switzerland	0	578	0	0.00

What this means for a device maker entering the EU

Your importer is a legal role, not a sales title. If you make devices outside the EU, someone must be the importer of record. That company carries duties under the MDR. Decide who it is on purpose, and keep it separate from your authorised representative unless you have a reason not to.

Small markets run on importers. Where importers outnumber makers several times over, almost every device arrives through a local importer. Expect many candidates, and expect most of them to carry competing lines. Ask who they already import for.

Big markets are crowded with makers. In Germany and Italy you compete with domestic manufacturers for the attention of the same importers. A clear reason to carry your line matters more than the size of the list.

The register is a starting list, not a shortlist. Some importers are a manufacturer's own EU subsidiary and will never carry your device. National distributors of devices already on the EU market do not appear at all. Use the list to see the shape of a market, then qualify.

The country pages list the importers and authorised representatives behind these counts, with the source and date on every record. The Distributor Index lets you search them by device.

Entering the EU? Get up to ten ranked importers and distributors in each of your best EU markets. Rank my next 10 markets, €490

Methodology

Source. The EUDAMED actor registration module, read through the European Commission's public Datalake API (api.datalake.sante.service.ec.europa.eu/eudamed/actors), one request per country and actor type. No key or login. Snapshot taken on 2026-10-22; the Index build was generated at 2026-10-22T16:52:17Z.

Unit. One registration is one Single Registration Number (SRN). An SRN is issued per role, so a company that is both a manufacturer and an importer counts once in each column. Inactive actors are excluded. Repeated rows for the same SRN are kept once.

Definitions. Importers are EUDAMED importer registrations: companies that place devices made outside the Union on the EU market. Manufacturers are manufacturer registrations (15,984) plus system or procedure pack producer registrations (1,300). Authorised representatives are shown for context. Country is the actor's registered country.

Scope. EU27, Iceland, Liechtenstein, Norway, Türkiye, Switzerland and Northern Ireland: 33 jurisdictions. The EU27 alone: 11,790 importers and 15,324 manufacturers. Manufacturers outside Europe that register through an EU authorised representative keep their own country code and are not counted.

Caveats. An importer is not a national distributor; dealers of devices already on the EU market are not in EUDAMED. Many importer rows are manufacturers' own EU subsidiaries, and the register does not mark them. Coverage of Switzerland and Türkiye depends on bilateral arrangements and is partial. Contact fields are self-declared. This is one snapshot: we cannot yet say how the counts changed after the mandatory date, and we will not guess. Monthly snapshots start in November 2026.

Attribution. Source: EUDAMED (European Commission), CC BY 4.0; data filtered and reformatted by Bastion Hale. Full source notes on the methodology page.

How to cite

Bastion Hale (2026). Who imports medical devices into the EU: the 2026 importer map. 23 October 2026. Data: EUDAMED actor module, snapshot of 22 October 2026. https://bastionhale.com/insights/eu-medical-device-importers-2026/

The per-country table is at https://bastionhale.com/insights/eu-medical-device-importers-2026/data.csv. Counts change as companies register, so quote the snapshot date.

Questions people ask

How many medical device importers are registered in EUDAMED?

In our snapshot of 22 October 2026, the EUDAMED actor module listed 12,612 active importer registrations across the 33 jurisdictions we pulled (EU27, Iceland, Liechtenstein, Norway, Northern Ireland, Switzerland and Türkiye), against 17,284 manufacturer and system or procedure pack producer registrations.

Which EU country has the most medical device importers?

Germany, with 1,990 importer registrations, about 16 percent of the total. Spain (1,129) and Italy (1,070) follow. Germany also has 3,606 manufacturer registrations, so its ratio of importers to manufacturers is only 0.55.

Is an EUDAMED importer the same as a distributor?

No. Under the MDR an importer is the company that first places a device made outside the EU on the EU market. A distributor that only resells devices already on the market does not register in EUDAMED at all. Many importers also distribute, and some are manufacturers' own EU subsidiaries; the register does not say which.

Can I use these numbers?

Yes, with credit. Download the per-country table as CSV from this page and cite it as: Bastion Hale, "Who imports medical devices into the EU: the 2026 importer map", 23 October 2026, https://bastionhale.com/insights/eu-medical-device-importers-2026/. The source data is EUDAMED (European Commission), CC BY 4.0.