EUDAMED Becomes Mandatory on 2026-05-28: What IVDR Businesses Must Do

1. Key takeaways

Commission Decision (EU) 2025/2371 (adopted 2025-11-26, published in the OJEU on 2025-11-27) declares the first four electronic system functions of EUDAMED functional and compliant with the functional specifications, triggering a 6-month transition under the gradual roll-out mechanism of (EU) 2024/1860. From 2026-05-28, the use of four modules is mandatory: actor registration (Actor), UDI and device registration (UDI/Devices), notified bodies and certificates (Notified Bodies & Certificates), and market surveillance (Market Surveillance, aimed at competent authorities). The remaining two modules (vigilance and post-market surveillance, and clinical investigations and performance studies) are still in development and can only become mandatory after a further notice in the Official Journal. Businesses should read the mandatory date as a hard deadline for actor registration and device registration, while continuing to track the second notice for the remaining modules without assuming any particular timing.

2. Legal basis

3. Expert insights

Insight 1: After the mandatory date, new devices and legacy devices follow two separate routes.

From 2026-05-28, new device registrations (Article 26 of the IVDR) must be entered in EUDAMED, replacing the local systems previously accepted by some Member States. Legacy devices, under the gradual roll-out arrangement, receive a back-registration window of 6 months from the mandatory date, meaning registration must be completed by 2026-11-28, and the system-generated EUDAMED-DI can be used without a Basic UDI-DI first being assigned by the issuing body. Companies with mixed portfolios should therefore run two tracks in parallel: one ensuring new devices are registered as they are placed on the market, and one scheduling every legacy device into the window before it closes.

Insight 2: Actor registration is the gating step; without an SRN no device record can be submitted.

The SRN is the foreign key of the device data. Where the actor record has not been approved (SRN not activated), the device module rejects submissions referencing that SRN. The compliance sequence for a non-EU manufacturer is therefore: appointment of the authorised representative (Article 11), actor registration to obtain the SRN (Article 28), and then submission of device and UDI data (Article 26). Compression at the end of the pipeline is impossible, because the competent authority verification of the actor record introduces lead time outside the company control, so the sequence must start well before any certificate-dependent deadline.

Insight 3: The publicity of certificates and the SSP rises sharply after the mandatory date.

Article 51(5) (applicable from 2023-11-27) requires notified bodies to enter into the electronic system of Article 52 information on the issue, amendment, supplement, suspension, reinstatement, withdrawal, refusal and restriction of certificates and to make it public; Article 29(1) requires the summary of safety and performance to be validated by the notified body, uploaded to EUDAMED and made available to the public. After the mandatory date, these data become directly retrievable public information, which raises the compliance bar: incorrect certificate details, outdated SSP versions or mismatched actor names are visible to buyers and authorities without any formal request.

Insight 4: The mandatory timing of the last two modules still awaits a new notice.

The vigilance and post-market surveillance module and the clinical investigations and performance studies module have not yet been declared functional. Until they become mandatory, the reporting obligations under Articles 82 and 83 and performance study applications continue to follow the existing arrangements, including Member State level ones. Businesses should track the Commission notices in the Official Journal for the functional declaration of these modules, and treat any assumed date for them as unconfirmed, since the mechanism of (EU) 2024/1860 requires the publication step before the 6-month transition can start.

4. Practical recommendations

1. Check the entire marketed portfolio: whether new devices are registered in EUDAMED under Article 26, and whether legacy devices are scheduled for back-registration before 2026-11-28.
2. Treat the SRN as a compliance precondition and verify that the public fields of the actor data in EUDAMED are correct.
3. Set an annual EUDAMED data maintenance calendar (updates within 1 week of change; confirmation at 1 year and every 2 years).
4. Review the public status and version consistency of the SSP and certificate information in EUDAMED.
5. Track the functional notices for the vigilance and performance studies modules (no fixed date yet; a pending tracking item).

5. Verification checklist

• □ Confirmed that the first four modules are mandatory from 2026-05-28
• □ New devices registered in EUDAMED under Article 26, with no further use of Member State local substitute routes
• □ Legacy devices scheduled for back-registration before 2026-11-28, using EUDAMED-DI confirmed
• □ SRN obtained and in activated status (Article 28)
• □ Public status and versions of SSP and certificate information in EUDAMED reviewed
• □ Functional notices for the last two modules added to the regulatory tracking list

Legal information verified as of 2026-10-29.

GRZAN supports in vitro diagnostic manufacturers entering the EU market under Regulation (EU) 2017/746 as EU Authorised Representative (EC REP) and PRRC provider, including EUDAMED actor and device registration, legacy device back-registration planning, SRN and data maintenance calendars and fee budgeting. For EUDAMED readiness support, contact info@grzanglobal.com.