EUDAMED becomes mandatory on May 28, 2026. Is your portfolio ready?

After years of phased delays and voluntary participation, four core EUDAMED modules become mandatory under EU MDR and IVDR on May 28, 2026. For manufacturers, importers, and EU Authorized Representatives, this is a hard regulatory deadline, not a guideline.

What's changing?

The European Commission's EUDAMED database was designed to consolidate device identification, certification, and surveillance data across the EU single market. As of May 28, the following four modules move from optional to mandatory under both EU MDR (2017/745) and IVDR (2017/746):

• Actor Registration (SRN). Every economic operator (manufacturer, importer, Authorized Representative) must be registered and hold a Single Registration Number. This is the prerequisite for everything else in EUDAMED. Nothing else works without it. Each country's national authority reviews and approves registrations before issuing an SRN, and processing times vary. If you haven't started this process, start now.

• UDI / Device Registration. Devices must be registered in EUDAMED before they can be placed on the EU market. New devices cannot be listed from May 28 without it.

• Notified Bodies and Certificates. Certificates issued by Notified Bodies will be publicly visible in real time through EUDAMED, providing transparency for buyers and regulators across the single market.

• Market Surveillance. Competent Authorities will use EUDAMED to record and share market surveillance activities across member states, reinforcing cross-border regulatory coordination.

  
  

Key EUDAMED deadlines

Deadline	Requirement
Now to May 28, 2026	Complete Actor Registration and obtain your SRN. National authorities review and approve each submission before issuing an SRN, and processing times vary by country. As the deadline approaches, expect longer waits.
May 28, 2026	All four modules become mandatory. New devices cannot be placed on the EU market without EUDAMED registration.
November 27, 2026	Legacy devices already on the market as of May 28 must be registered in EUDAMED by this date.
TBD	Vigilance and Clinical Investigations modules will become mandatory on their own separate timelines.

Note on national systems:

For the obligations covered by the four mandatory modules, EUDAMED replaces national registration systems as of May 28. Parallel national processes are no longer sufficient for actor and device registration. Some member states may retain additional national requirements outside the scope of these modules, so check with your local Competent Authority if you have country-specific obligations.

What this means in practice

Data quality is the hidden risk

Your EUDAMED registrations must be consistent with your technical documentation, labeling, and IFU. For large portfolios, mismatches create compliance exposure and can trigger regulatory scrutiny. Audit your UDI data before you upload, not after.

Non-EU manufacturers

Your EU Authorized Representative's registration status will now be publicly visible in real time through EUDAMED. Any change to that relationship, including termination, will be immediately visible to regulators and the market.

Vigilance and Clinical Investigations modules are still coming

Two additional modules will follow with their own mandatory dates. Until those modules become mandatory, manufacturers must continue reporting directly to national Competent Authorities. Organizations should build EUDAMED fluency now rather than managing each module transition as a separate exercise.

Where to start

If your team hasn't mapped your portfolio against these timelines, that is the starting point. Prioritize Actor Registration, as everything downstream depends on it. Because each country's national authority must individually review and approve your registration before issuing an SRN, submissions close to the May 28 deadline risk delays that could block your device registrations. Then sequence your UDI and device registration work based on product priority.

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Questions about your EUDAMED readiness?

Quarem Consulting works with medical device and IVD manufacturers on EUDAMED registration, UDI data audits, and EU MDR / IVDR regulatory strategy. If you need help mapping your portfolio or sequencing your registration work, reach out to us.