EUDAMED becomes mandatory 28 May 2026 — your action checklist

Why 28 May 2026 is the date every SaMD company needs in their calendar

On 26 November 2025, the European Commission confirmed the functionality of four EUDAMED modules and triggered a six-month transition period. The clock has been ticking since that announcement — and it ends on 28 May 2026, when use of these modules becomes legally mandatory.

This is not a soft deadline. Once the obligation kicks in, placing a medical device — including software as a medical device — on the EU market without completing EUDAMED registration is a regulatory violation. National competent authorities have enforcement powers ranging from fines to market withdrawal.

The four modules going live — what each one requires

Module 1: Registration of economic operators

Every economic operator in the EU medical device supply chain — manufacturers, importers, authorised representatives, and distributors with specific obligations — must register in EUDAMED and obtain a Single Registration Number (SRN). For non-EU manufacturers, your EU Authorised Representative registers on your behalf and links your organisation to their account.

The SRN is the foundation of everything else. You need it before you can register devices or UDIs. If you haven't started this process, start now — the SRN is issued by national competent authorities (the MHRA equivalent in each EU member state), and processing times vary by country.

Module 2: UDI database and device registration

From 28 May 2026, all medical devices must be registered in the EUDAMED UDI database before being placed on the EU market for the first time. Devices already on the market must also be registered — this is a retrospective requirement for the existing installed base.

For software, the UDI assignment rules are specific: the Basic UDI-DI identifies the device model, while the UDI-PI (production identifier) captures the software version. Every major software release that constitutes a new device version requires its own UDI registration. This creates an ongoing administrative obligation that must be built into your change management process.

Module 3: Notified Bodies and certificates

CE certificates issued by Notified Bodies must be recorded in EUDAMED. In practice, your Notified Body uploads the certificate data directly — but you need to ensure your NB is doing this, and that the certificate data is accurate and linked to your device registrations. Check with your NB now.

Module 4: Market surveillance

Vigilance data — serious incidents, field safety corrective actions (FSCAs), and periodic safety update reports (PSURs) — must be reported through EUDAMED once the module is live. Your post-market surveillance process needs to be configured to feed into EUDAMED rather than (or in addition to) direct national authority notification.

Your EUDAMED action checklist — by priority

1. Identify your registration country: Non-EU manufacturers register through the country where their EU Authorised Representative is established. EU manufacturers register in their own country.
2. Apply for your SRN immediately: Contact the national competent authority in your registration country. Processing times can be 4–8 weeks in some countries — do not leave this until April.
3. Audit your device portfolio: List every SaMD you sell in the EU. Identify the Basic UDI-DI for each device and every software version that constitutes a separate UDI-PI.
4. Assign UDIs if not already done: Work with an accredited issuing agency (GS1, HIBCC, or ICCBBA) to assign Basic UDI-DIs and create your UDI labelling.
5. Register all devices in EUDAMED: Once you have your SRN, register each device and its associated UDI data. Ensure your NB certificates are correctly linked.
6. Update your QMS and PMS processes: Your post-market surveillance SOP and PSUR process need to include EUDAMED submission steps. Internal audit your QMS against the new requirements before the deadline.
7. Brief your EU Authorised Representative: If you use an EUAR, ensure they understand their EUDAMED obligations and have confirmed they are ready to register and manage your account.

Common mistakes SaMD companies make with EUDAMED

Waiting for the NB to handle everything. Your Notified Body uploads certificate data, but the operator registration, device registration, and UDI database entries are your responsibility. Don't assume your NB will do it.

Confusing the Basic UDI-DI with version-specific UDI-PI. For software, every release that changes the intended use, performance, or safety characteristics is a new UDI-PI. Your EUDAMED entries need to reflect current and historical versions correctly.

Missing the SRN application window. The SRN process goes through national competent authorities, not EUDAMED itself. Some countries process these quickly; others take weeks. Apply now.

Ignoring the retroactive requirement. EUDAMED registration is not just for new devices — existing devices on the EU market must also be registered. Many companies are only thinking about new product launches and missing the obligation for their existing portfolio.

How EUDAMED fits into the wider 2026 regulatory picture

EUDAMED's mandatory launch is one of several major developments hitting the EU medical device market in 2026. Alongside it, the EU AI Act's high-risk AI provisions apply from August 2026, the Notified Body capacity crisis is worsening certification timelines, and the EU Commission's December 2025 MDR simplification proposal is working its way through the legislative process.

For SaMD companies, 2026 requires more regulatory resource than any year since MDR entered into force in 2021. Companies that plan ahead — setting up EUDAMED accounts now, engaging Notified Bodies early, and building regulatory change into their QMS — will maintain uninterrupted market access. Companies that react will face delays, disruptions, and potential gaps in their ability to sell.