EUDAMED Readiness Check

Since May 28, 2026, four EUDAMED modules have been mandatory: actor registration (SRN), UDI and device registration, notified bodies and certificates, and market surveillance. Check in a few minutes whether your prerequisites under MDR (EU 2017/745) / IVDR (EU 2017/746) are in place.

Question 1 of 6

Have you applied for and received an SRN (Single Registration Number)?

Actor registration, MDR Art. 31.

Orientation only, not a substitute for a regulatory assessment.

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Regulatory due diligence: the deadlines and registers against which a data room is measured (MDR Art. 120, IVDR Art. 110, EUDAMED, Art. 16 and 10a)

A data room shows what the target company produces. Whether that is enough is decided by the legal text: MDR Art. 120 ties continued sales under an MDD certificate to May 26, 2024, and September 26, 2024, IVDR Art. 110 sets staggered dates up to 2027, EUDAMED has been mandatory in four modules since May 28, 2026, and Art. 16 MDR turns a buyer who sells the device under its own name after closing into the manufacturer with all obligations. There are also three public registers: EudraGMDP, the EUDAMED module "Notified Bodies & Certificates" and the FDA Warning Letter database. What a regulatory due diligence has to establish per device, with references.

ArticleApr 15, 2026

EUDAMED Readiness: Why Registrations Fail in Practice

Since May 28, 2026, the first four EUDAMED modules are mandatory: actors, UDI and devices, notified bodies and certificates, market surveillance. For legacy devices that stay on the market, the registration deadline is November 28, 2026. Four problem clusters we encounter time and again.

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