European
Compliance Platform
European
Compliance Platform
Step-by-Step Guide for Medical Device Manufacturers
Mandatory from May 2026: The full EUDAMED mandate under Article 33 MDR 2017/745 took effect in May 2026. Any medical device placed on the EU market on or after this date must be registered in EUDAMED before sale. Devices without an active EUDAMED registration cannot legally be placed on the EU market.
EUDAMED (European Database on Medical Devices) is the EU's central database for medical device registration, UDI management, and certificate tracking. ECP has registered devices in EUDAMED for real clients — this guide reflects practical experience with the registration process, not only regulatory text.
| Entity / Device | What to Register | Mandatory Since |
|---|---|---|
| Non-EU manufacturer | SRN (Single Registration Number) as economic operator | May 2021 |
| EU Authorised Representative (EC REP) | SRN as economic operator + mandate link to manufacturer | May 2021 |
| EU importer / distributor | SRN as economic operator (where applicable) | May 2021 |
| Medical device — Class I | Basic UDI-DI, device data, self-declaration reference | May 2026 |
| Medical device — Class IIa | Basic UDI-DI, device data, Notified Body certificate link | May 2026 |
| Medical device — Class IIb / III | Full UDI-DI + device data + NB certificate link (required before device record activation) | May 2026 |
| IVD — Class A / B (self-cert) | Basic UDI-DI, device data, performance evaluation | IVDR deadline |
| IVD — Class C / D (NB-assessed) | Full UDI-DI + IVDR certificate link | IVDR deadline |
Apply for an EORI (Economic Operator Registration and Identification) number from the customs authority of your EU Member State. Non-EU manufacturers must do this through their EU Authorised Representative's country. EORI is required before any EUDAMED account can be created.
Create an account in EUDAMED and register your organisation as an economic operator (manufacturer, authorised representative, importer, or distributor). Upon approval by the competent authority, you receive a Single Registration Number (SRN) — a unique identifier in the format XX/YYYYYYY/XXXXXX required for all device registrations.
Non-EU manufacturers must establish the mandate link between their company and the EU Authorised Representative (EC REP) in EUDAMED. The EC REP must already have their SRN. The mandate specifies which devices the EC REP is responsible for and must be accepted by both parties in EUDAMED before any device records can be created under this manufacturer.
For each device, create a device record in EUDAMED. Assign a Basic UDI-DI issued by an accredited issuing entity: GS1, HIBCC, ICCBBA, or IFA. Enter all required device data: name, intended purpose, risk class, GMDN code, applicable harmonised standards or Common Specifications, and device characteristics.
For Class IIb and Class III devices, link the MDR Notified Body certificate to the device record. The certificate reference in EUDAMED must match the Basic UDI-DI on the certificate document exactly. For Class IIa devices, certificate linking is required but device registration can proceed to submission while the certificate is being finalised in parallel.
Submit the complete device record for review. The competent authority of the relevant Member State reviews the submission for completeness and compliance. Upon validation, the device receives active EUDAMED status. Only devices with active status may legally be placed on the EU market after May 2026.
Yes. The full EUDAMED mandate under Article 33 MDR 2017/745 took effect in May 2026. Any medical device placed on the EU market on or after this date must be registered in EUDAMED before sale. Manufacturers and EU Authorised Representatives were required to obtain their SRN from May 2021 — if this has not been done, it must be completed immediately before device records can be created.
Total registration time is typically 4–10 weeks, depending on whether your EC REP is already registered and the competent authority review timeline. The main bottleneck is EC REP SRN registration (2–4 weeks if not already done) — this must complete before device records can be submitted. Competent authority review of device submissions typically takes 1–3 weeks. Plan for at least 6 weeks from start to active status, and start well before your planned EU market launch date.
For Class I devices: No. You self-certify and register device data directly without NB involvement. For Class IIa: Notified Body certification is required, but EUDAMED registration can begin in parallel — the NB certificate is linked once issued. For Class IIb and III: The Notified Body certificate must exist and be linked to the device record before EUDAMED registration is complete. You cannot activate a Class IIb/III device record without the certificate reference.
A Basic UDI-DI (Unique Device Identifier — Device Identifier at Basic UDI level) is the primary key that identifies a device model in EUDAMED. It represents the device design and intended purpose, independent of packaging. It must be issued before EUDAMED registration by an accredited issuing entity (GS1, HIBCC, ICCBBA, or IFA). Every device record, NB certificate, and UDI label must reference the same Basic UDI-DI — mismatches between these cause registration rejection or compliance findings during surveillance.
Contact your EU Authorised Representative immediately. Ask them to confirm whether they have an active EUDAMED SRN. If they do not, this must be resolved before device registration can begin — it adds 2–6 weeks depending on their competent authority. If your EC REP is unwilling or unable to complete EUDAMED registration, consider switching to a compliant EC REP service. ECP can connect you with EU Authorised Representatives already registered in EUDAMED.
If your EC REP hasn't registered you in EUDAMED yet — act now
ECP connects non-EU manufacturers with EU Authorised Representatives already registered in EUDAMED. Submit a request and receive structured responses from EAR service providers who can complete your EUDAMED registration process.