EUDAMED Actor Registration and the SRN Under IVDR Article 28

1. Key takeaways

Article 27 provides the electronic system for the registration of economic operators, and Article 28 requires manufacturers, authorised representatives and importers to submit the information of Section 1 of Part A of Annex VI to that system before placing devices on the market, obtaining a Single Registration Number (SRN) after verification by a competent authority. Article 28(3) states the purpose precisely: the SRN is used when submitting an application for conformity assessment to a notified body and when accessing EUDAMED to fulfil the obligations of Article 26. From 2026-05-28, the first four modules of EUDAMED are mandatory, and the SRN becomes a substantive precondition for non-EU manufacturers: without an activated SRN, conformity assessment applications, device registration and public retrievability of actor data all stall, because every downstream submission in EUDAMED references the actor record as its foreign key.

2. Legal basis

3. Expert insights

Insight 1: One key opens three locks.

Article 28(3) writes the purposes of the SRN clearly: submitting an application for conformity assessment to a notified body, and accessing EUDAMED to fulfil the device registration obligations of Article 26. In addition, Article 29(2)(a) requires the summary of safety and performance to state the SRN, where one has been issued. Without an SRN, three things stall simultaneously: the conformity assessment application, the device registration, and the publication of the actor data. For project planning, this makes the SRN the first milestone of any EU IVD launch, because every downstream dependency — notified body contracting, Annex VI device data submission, the summary of safety and performance — assumes an actor record that a competent authority has verified.

Insight 2: Registration data follow a dual rhythm of updating and confirming.

Article 28(4): information must be updated within 1 week of any change. Article 28(5): within 1 year of submitting the information, and thereafter every 2 years, the accuracy of the data must be confirmed; if the confirmation does not take place within 6 months of the respective deadline, any Member State may take appropriate corrective measures within its territory. Article 28(6) adds that, without prejudice to the responsibility of economic operators for the data, the competent authority shall verify the confirmed data. Companies should treat the two rhythms as separate calendar obligations: the one-week update clock runs on every corporate change (name, address, contact persons), while the one-year and two-year confirmation clocks run on fixed dates from the original submission.

Insight 3: Data publicity and fees are written in the same article.

Article 28(7): the data referred to in paragraph 1 shall be publicly available. Article 28(8): competent authorities may charge manufacturers, authorised representatives or importers in accordance with Article 104. Registration is therefore both an obligation and a publicly retrievable compliance signal: customers, competitors and authorities can see whether an actor record exists, who the verified contacts are and whether the record looks maintained. A stale public record is a reputational and enforcement exposure at the same time, since the corrective-measure mechanism of Article 28(5) can be triggered precisely by unconfirmed data.

Insight 4: From 2026-05-28 there is no Member State substitute route for actor registration.

Under Commission Decision (EU) 2025/2371 (adopted 2025-11-26, published in the OJEU on 2025-11-27) and the gradual roll-out mechanism of (EU) 2024/1860, the first four modules become mandatory from 2026-05-28, and actor registration is among them. Local substitute arrangements previously accepted by some Member States no longer serve as a compliance route (see the dedicated article on the EUDAMED mandatory date in this series). Actors that postponed registration on the assumption that a national workaround would remain available should re-plan immediately, because the verification step by the competent authority adds time that cannot be compressed at the deadline.

4. Practical recommendations

1. Make the SRN the first milestone of project start-up, ahead of the notified body application and device registration.
2. Assign an owner for the Annex VI Part A Section 1 information and set calendar reminders for the 1-week updates and the 1-year / 2-year confirmations.
3. Add a check on whether EUDAMED actor data are synchronised to the change management process.
4. Confirm whether the Member State concerned charges fees under Article 28(8) together with Article 104, and include them in the annual budget.
5. Register legacy devices through the EUDAMED-DI route and check the data items against MDCG 2019-5.

5. Verification checklist

• □ Manufacturer, authorised representative and importer all registered under Article 28 with SRNs obtained
• □ Annex VI Part A Section 1 information submitted in full and verified by a competent authority
• □ Mechanism for updates within 1 week of change established (Article 28(4))
• □ Calendar set for confirmation at 1 year and every 2 years thereafter (Article 28(5))
• □ Public data scope confirmed (Article 28(7)) together with Member State fees (Articles 28(8) and 104)
• □ Back-registration route for legacy devices (EUDAMED-DI) confirmed

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 registration and SRN acquisition, Annex VI data preparation, confirmation calendars and fee budgeting. For EUDAMED registration support, contact info@grzanglobal.com.