Developer guides

EUDAMED deadline: what manufacturers must register by 28 November 2026

Devices placed on the EU market before 28 May 2026 and still placed on the market after it, legacy devices included, must be registered in the EUDAMED UDI/Device module by 28 November 2026: 12 months after the Commission notice confirming the module was published in the Official Journal on 27 November 2025. Source: Arcadium Data, data as of 2026-10-25.

EUDAMED is the European database on medical devices that the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) set up. For years most of it could be used voluntarily only. Regulation (EU) 2024/1860 changed the approach: each module becomes mandatory on its own, six months after the European Commission publishes a notice in the Official Journal of the EU confirming that the module works.

That notice for the first four modules (actor registration, UDI/device registration, notified bodies and certificates, market surveillance) is Commission Decision (EU) 2025/2371, published on 27 November 2025. The four modules have therefore been mandatory since 28 May 2026. This guide sets out, in plain terms, what follows from that for manufacturers, authorised representatives and importers, with the official documents linked at each step. It is a summary, not legal advice: where a case is unclear, the MDCG guidance and the competent authority decide.

The official route: what the rules require

The dates

How the 28 November 2026 date is reached: the Q&A document on the gradual roll-out (MDCG 2024-11) says that a device whose first unit was placed on the market before the date of mandatory use, and whose further units are placed on the market on or after that date, must be registered "within 12 months from the publication in the OJEU of the notice confirming the functionality of the UDI/DEV module". Its own worked example uses a notice of 1 July 2025, mandatory use from 2 January 2026 and registration by 2 July 2026. Applied to the real notice of 27 November 2025, that gives mandatory use from 28 May 2026 and registration by 28 November 2026.

Step 1: the actor registration and the SRN

Every manufacturer, authorised representative, importer and system or procedure pack producer registers once in the actor module. After the national competent authority validates the request, EUDAMED issues a Single Registration Number (SRN) such as DE-MF-000006463: the country of the registered seat, the role (MF, AR, IM or PR) and a serial number. A manufacturer cannot register a device without an SRN, and a manufacturer outside the EU needs an authorised representative established in the EU, which has its own SRN. Since 28 May 2026 the actor registration is an obligation, not an option.

Step 2: device registration in the UDI/Device module

Devices are registered at the level of the device identifier, not of each unit: one registration per UDI-DI (with its Basic UDI-DI) covers every unit that carries it, whatever the lot or serial number. The Q&A separates three situations.

• Devices placed on the market for the first time on or after 28 May 2026. Registration comes first: it must be done before the first unit is placed on the EU market. There is no transition period.
• Devices already on the market before 28 May 2026 that are still being placed on the market after it. This covers devices certified under the MDR or IVDR and legacy devices, which are devices still placed on the market under a certificate or declaration issued under the old directives (MDD, AIMDD, IVDD) during the transition periods. They must be registered by 28 November 2026. Legacy devices are registered with a EUDAMED DI or, where they have one, a UDI-DI.
• Devices no longer placed on the market from 28 May 2026. No registration is needed, unless a vigilance or post-market surveillance action concerns them; then the device has to be registered so that the action can refer to it.

Two further points from the same document matter in practice. A legacy device does not need its own registration when "the same device" is already registered as a device under the Regulation, meaning the same identification such as UDI-DI, catalogue or reference number, or trade name. Custom-made devices, investigational devices and devices for performance studies are not registered in the UDI/Device module.

Step 3: certificates

Notified bodies enter certificates in the notified body and certificate module. Any certificate issued after the module became mandatory must be registered there, and updates and decisions taken after that date on certificates issued earlier (a suspension, a withdrawal, a restriction) must be registered too. For a manufacturer the practical consequence is that the certificates its devices rely on become visible next to its devices in the public search.

What is not mandatory yet

The vigilance and post-market surveillance module and the clinical investigation and performance study module are not mandatory. The Commission says they will become mandatory through their own notices, without a period of voluntary use first. Until then the national systems and the rules of the directives continue to apply for those processes.

Checking a company yourself in EUDAMED

The public EUDAMED site at ec.europa.eu/tools/eudamed lets anyone search actors, devices and certificates without an account. The site is a single-page application over a JSON interface that answers anonymous GET requests, and the Commission's public API guide states that the public data may be downloaded by anyone. The calls below look up a manufacturer by SRN and list its devices. Pages hold at most 300 rows, and requests should be paced (we use one per second).

curl

# actor (economic operator) by SRN
curl -s "https://ec.europa.eu/tools/eudamed/api/eos?srn=DE-MF-000006463&page=0&size=10&iso2Code=en&languageIso2Code=en"
# devices of that manufacturer, newest first
curl -s "https://ec.europa.eu/tools/eudamed/api/devices/udiDiData?srn=DE-MF-000006463&page=0&size=300&iso2Code=en&languageIso2Code=en"

Python

import time
import requests

BASE = "https://ec.europa.eu/tools/eudamed/api"
COMMON = {"iso2Code": "en", "languageIso2Code": "en"}

def devices_of(srn: str, max_pages: int = 50) -> list[dict]:
    """Every UDI-DI row EUDAMED lists for one manufacturer SRN (300 rows a page)."""
    rows, page = [], 0
    while page < max_pages:
        r = requests.get(f"{BASE}/devices/udiDiData",
                         params={**COMMON, "srn": srn, "page": page, "size": 300}, timeout=60)
        r.raise_for_status()
        batch = r.json().get("content", [])
        rows += batch
        if len(batch) < 300:
            return rows
        page += 1
        time.sleep(1)  # be polite to a public service
    return rows

print(len(devices_of("DE-MF-000006463")))

TypeScript

const BASE = 'https://ec.europa.eu/tools/eudamed/api';

export async function devicesOf(srn: string, maxPages = 50): Promise<unknown[]> {
  const rows: unknown[] = [];
  for (let page = 0; page < maxPages; page++) {
    const q = new URLSearchParams({ srn, page: String(page), size: '300', iso2Code: 'en', languageIso2Code: 'en' });
    const res = await fetch(BASE + '/devices/udiDiData?' + q, { signal: AbortSignal.timeout(60_000) });
    if (!res.ok) throw new Error('EUDAMED ' + res.status);
    const batch = ((await res.json()) as { content?: unknown[] }).content ?? [];
    rows.push(...batch);
    if (batch.length < 300) break;
    await new Promise((r) => setTimeout(r, 1000));
  }
  return rows;
}

The responses are the same data the public search shows. They do not say whether a device is a legacy device or whether a company still owes a registration: EUDAMED records what was registered, not what should have been. Actor records also carry contact details of the economic operator, which you should not copy into your own systems without a reason and a legal basis.

The fast route: the free checker and one API call

The EUDAMED registration checker answers the common question in one step: type a manufacturer name, an SRN or a website domain and see whether the company has an SRN, how many devices and valid certificates it has registered, and the days left to 28 November 2026. Country pages list the registered companies of each seat, with the manufacturers that have no device registered yet first. Both are company-level and need no sign-up.

For code, the Arcadium Data API keeps EUDAMED actors, devices and certificates in one place, joined to the company's website domain and the US FDA registration and listing data, and records changes as dated events.

Calls on this page work without a key from one IP (10 requests a minute, 100 a day, short answers, point lookups). A free key lifts the limits: sign up. Routes, parameters and fields: OpenAPI.

curl

# one manufacturer by SRN or by website domain
curl -s "https://api.arcadiumdata.io/v1/devices/manufacturers?srn=DE-MF-000006463"
curl -s "https://api.arcadiumdata.io/v1/devices/manufacturers?domain=silony-medical.com"
# its registered devices
curl -s "https://api.arcadiumdata.io/v1/devices?manufacturer_srn=DE-MF-000006463&limit=50"

Response (abridged)

{
  "data": [{
    "srn": "DE-MF-000006463",
    "country": "DE",
    "domain": "silony-medical.com",
    "name": "Silony Medical GmbH",
    "devices": { "total": 600, "onMarket": 600, "byRiskClass": { "class-i": 402, "class-iia": 198 } },
    "certificates": { "issued": 0, "expiringWithin90Days": 0 }
  }]
}

Python

import requests

URL = "https://api.arcadiumdata.io/v1/devices/manufacturers"

def manufacturers_without_devices(country: str, key: str) -> list[dict]:
    """Manufacturers of one country with an SRN and no device registered yet (a free key pages through all)."""
    out, cursor = [], None
    while True:
        params = {"country": country, "no_devices": "true", "limit": 100}
        if cursor:
            params["cursor"] = cursor
        r = requests.get(URL, params=params,
                         headers={"authorization": f"Bearer {key}"}, timeout=30)
        r.raise_for_status()
        body = r.json()
        out += body["data"]
        cursor = body.get("nextCursor")
        if not cursor:
            return out

TypeScript

export async function registrationStatus(domain: string) {
  const res = await fetch('https://api.arcadiumdata.io/v1/devices/manufacturers?domain=' + encodeURIComponent(domain));
  const body = (await res.json()) as { data: Array<{ srn: string; devices: { total: number } }> };
  return body.data.map((m) => ({ srn: m.srn, devices: m.devices.total, hasDevices: m.devices.total > 0 }));
}

Change events (/v1/devices/events) record when a manufacturer registers its first device, adds devices or gains or loses a certificate, so a list can be watched until the deadline instead of being checked again by hand. AI agents get the same answers through the MCP server. Whole-dataset delivery as daily files is on the data licence page.

Comparison

Related

• EUDAMED registration checker
• Medical-device manufacturers in EUDAMED with FDA status
• Manufacturers with no device registered yet
• Dataset licence
• MCP server

Sources

• Q&A on the gradual roll-out of EUDAMED (MDCG 2024-11, European Commission)
• The EUDAMED four first modules will be mandatory to use as from 28 May 2026 (European Commission, 27 Nov 2025)
• EUDAMED overview (European Commission)
• Regulation (EU) 2024/1860 (gradual roll-out of EUDAMED)
• EUDAMED public site (European Commission)

Last updated 2026-10-25. This guide is ours and independent of the organisations it describes. Found a mistake? Tell us and we correct it.

Cite as: Arcadium Data, "EUDAMED deadline: what manufacturers must register by 28 November 2026", https://arcadiumdata.io/guides/eudamed-deadline-what-manufacturers-must-register/, data as of 2026-10-25.