EUDAMED Mandatory Registration 2026 — What Every EU Importer Must Do

EUDAMED — the European Database on Medical Devices — is becoming fully mandatory for all manufacturers, importers, authorised representatives, and distributors. If you are involved in placing medical devices on the EU market and you are not registered, you will not be able to legally sell a single product after the enforcement date.

What is EUDAMED?

EUDAMED is the EU's centralised database for all medical devices sold in Europe. It stores information about every economic operator, every device, every certificate, every clinical investigation, and every post-market surveillance report. It is run by the European Commission and is the official registry that Competent Authorities across all 27 EU member states use to verify compliance.

Every company involved in the medical device supply chain in Europe must be registered in EUDAMED with a unique SRN (Single Registration Number). Without an SRN, you cannot legally place devices on the EU market.

Who must register in EUDAMED?

Manufacturers — all companies that design, produce, or place their name on a medical device
EU Authorized Representatives — companies appointed by non-EU manufacturers to represent them in Europe
Importers — any company based in the EU that brings devices from outside the EU into the EU market
Distributors — companies that make devices available on the EU market without being the manufacturer or importer

Critical warning: If you are a non-EU manufacturer, you cannot register in EUDAMED yourself — you must appoint an EU Authorized Representative first, and they register on your behalf. This is a legal requirement with no exceptions.

What happens if you miss the deadline?

Competent Authorities in each EU member state have the power to remove unregistered devices from the market with immediate effect. There are no grace periods after the enforcement date. The consequences include:

Immediate market suspension — your products are removed from sale
Product recalls — distributors and retailers must return stock
Financial penalties — fines vary by member state but can be substantial
Reputational damage — public enforcement actions are visible to your customers and partners

Step-by-step: What to do right now

Appoint an EU Authorized Representative (non-EU manufacturers only)

If your company is outside the EU, this must happen first. Your EU AR handles the EUDAMED registration process on your behalf and receives their own SRN which is linked to yours.

Gather your device information

You will need: GMDN codes for each device, UDI details (Basic UDI-DI), intended purpose, risk classification, and your Declaration of Conformity for each product.

Register as an Actor in EUDAMED

Complete the Actor registration form at ec.europa.eu/tools/eudamed to receive your SRN. This is your company's unique identifier in the EU system.

Register each device

After receiving your SRN, register each device in the Device module of EUDAMED. Link each device to both your manufacturer SRN and your EU AR's SRN.

Maintain annual updates

EUDAMED registration is not a one-time task. You must update your registration annually and whenever significant changes occur to your devices or company details.

How long does EUDAMED registration take? The complete process from appointing an EU AR to receiving your SRN and completing device registration typically takes 4 to 8 weeks. Do not wait until the last moment — start the process now to ensure you meet the deadline comfortably.

How NordMDR AB can help

NordMDR AB handles the complete EUDAMED registration process for manufacturers and importers across Europe — from Actor registration and SRN acquisition to full device registration, UDI database entries, and annual maintenance updates. Based in Stockholm, Sweden, we cover all 27 EU member states under a single AR agreement.

Need help with EUDAMED registration?

NordMDR AB manages the complete process for you. Sweden-based, Europe-wide, fixed fees. Free assessment — no obligation.

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EUDAMED Mandatory Registration — What Every EU Importer Must Do Right Now