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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Data study · updated monthly

EUDAMED compliance tracker: who actually registered

The first four EUDAMED modules became mandatory on 28 May 2026 (Decision (EU) 2025/2371). This tracker follows the public numbers as the market catches up — updated monthly.

Source: public EUDAMED data, extracted August 4, 2026.

48,685
registered economic operators
2,730,925
device records
4,180
public certificates

Key findings

  • 3,347 economic operators registered since May 2026 — the mandatory-use deadline produced the sharpest registration spike since the registry opened in December 2020.

  • China is the single largest country of origin: 7,408 registered Chinese economic operators, ahead of Germany (6,830), Italy (4,244) and France (3,125).

  • 34% of registered economic operators (16,484 of 48,685) are based outside the EU/EEA, Switzerland and the UK — 2,612 of them in the United States.

  • 2,730,925 device records are publicly visible; manufacturers outside Europe account for 47% of records with a known manufacturer country, including 253,332 from US manufacturers.

  • Legacy devices must be registered by 28 November 2026 — 17 weeks away at extraction — and unregistered devices are invisible to the database, so the true backlog is unknowable from EUDAMED alone.

Registrations over time: the deadline spike

Actor registration has been possible since December 2020 but only became compulsory on 28 May 2026. Of the 48,685 economic operators on record, 3,347 (7%) registered in or after May 2026.

Where the registrants are

Non-European operators are a structural part of EUDAMED: 16,484 of 48,685 registered economic operators (34%) are based outside the EU/EEA, Switzerland and the UK.

China leads the whole table with 7,408 registered operators — more than any EU member state. Germany follows with 6,830, then Italy (4,244), France (3,125) and the United States (2,612).

On the device side, manufacturers outside Europe account for 1,282,618 of 2,730,925 records with a known manufacturer country (47%), including 253,332 from the United States.

The legacy-device deadline: 28 November 2026

Devices already on the market before EUDAMED became mandatory (“legacy devices”) must be registered by 28 November 2026 — 17 weeks after this extraction. Unregistered devices are invisible to the database, so no one can compute the true backlog from EUDAMED alone. What we can measure is the pace at which devices are actually being registered.

77,117
device registrations per week (average over the 8 weeks through the week of July 20, 2026)
17
weeks until the legacy-device deadline
1,310,989
additional records at this pace by 28 Nov 2026
⚑

Method note: each record is bucketed on its EUDAMED registration date — the version-1 timestamp EUDAMED publishes for the record — not on the day MD Atlas ingested it. 64,268 of 2,730,925 device records (2.4%) carry no registration date in EUDAMED and are excluded from this series. The averaging window also stops short of the extraction date so that every week it counts has had time to fill, which makes the figure marginally conservative rather than inflated.

France vs Germany and Italy

France has 3,125 registered economic operators — behind Germany (6,830) and Italy (4,244).

The gap widens on devices: 96,461 records name a French manufacturer, versus 497,233 for Germany and 205,392 for Italy.

Methodology

Every number on this page comes from public EUDAMED data as ingested into the MD Atlas corpus, extracted on August 4, 2026. Aggregate tables only — no personal data. Every series is bucketed on a date EUDAMED itself publishes, never on the day MD Atlas ingested the record:

  • Economic operators — bucketed on the EUDAMED-provided registration date. Coverage: 48,684 of 48,685 rows carry the date (100%). Scope: economic operators only (manufacturers, importers, authorised representatives and system/procedure-pack producers); notified bodies and competent authorities are recorded separately by EUDAMED without a registration date.

  • Devices — bucketed on the EUDAMED-provided registration date (the record’s version-1 timestamp). Coverage: 2,666,657 of 2,730,925 records carry it (97.6%); the remaining 64,268 are excluded from the weekly series. Manufacturer-country coverage: 2,730,925 of 2,730,925 records (100%).

  • Certificates — bucketed on the EUDAMED-provided issue date. Coverage: 4,180 of 4,180 rows (100%).

Milestones referenced: mandatory use of the first four modules since 28 May 2026 (Decision (EU) 2025/2371); legacy-device registration by 28 November 2026; notified-body certificate uploads by 28 May 2027.

Download the data

The aggregate tables behind every chart on this page, as CSV. A free account is needed to download them. Free to reuse with attribution: “MD Atlas, public EUDAMED data, extracted August 4, 2026”.

Explore the registry yourself

MD Atlas is a fast search interface over the same public EUDAMED data — every company, device and certificate behind these numbers.

Search the databaseAbout the dataset