EUDAMED for Importers and Distributors: SRN Rules

Under EUDAMED, importers must register as actors and hold a Single Registration Number, and that registration has been mandatory since 28 May 2026. Distributors, in most cases, do not register at all. What distributors owe instead is traceability, and because that obligation has no portal to log into, it is the one that gets missed.

Most EUDAMED coverage is written for manufacturers. If you import devices into the EU or distribute them inside it, your obligations are different, smaller, and easier to get wrong precisely because they are smaller.

Which deadline is actually yours

Two dates get mixed up in almost every article on this topic, including some written for importers.

28 May 2026 is when the first EUDAMED modules became mandatory, actor registration among them. If you are an importer and you do not have an SRN yet, you are not early for a deadline. You are late.

28 November 2026 is the deadline for manufacturers to register devices, legacy and MDR devices alike, whose first unit was placed on the market before 28 May and which are still being placed on the market after it. The Commission's transition overview shows the timeline. That is the manufacturer's obligation, not yours. It becomes yours indirectly, because as an importer you have to verify that the device you place on the market has been registered.

If you are an importer

Your duties sit in two places in the MDR. Article 31 covers registration. Article 13 covers what you check and do before and after placing a device on the market.

You need an SRN (Article 31). You apply through the EUDAMED actor registration module, and your competent authority validates it. Validation is a human review, so it is the part of the process you do not control.

You verify before you place on the market (Article 13). The device carries a CE mark, the declaration of conformity exists, the manufacturer is identified and has an authorised representative where required, the label and instructions for use are in order, and a UDI has been assigned where applicable.

You verify that the device is registered. This is the one that catches people. If your supplier has not registered the device in EUDAMED, the manufacturer is still responsible for registering it, but you have an independent duty to check.

You appear on the device or its documents. Name, registered trade name or trade mark, and a contact address.

You keep a register of complaints, non-conforming devices, recalls and withdrawals, and you keep the manufacturer, the authorised representative and distributors informed.

If you are a distributor

Under Article 14 you are not required to register in EUDAMED as an actor. There is no SRN for you in the normal case.

What you do owe:

Verification before you make a device available. CE mark present, declaration of conformity available, labelling and instructions present, importer identified where applicable, UDI assigned where applicable.

Traceability, one step up and one step down (Article 25). You must be able to name the economic operator that supplied you, any economic operator you supplied, and any health institution or healthcare professional you supplied directly. The law asks for that chain. It does not, in general, ask for serial-level records.

The wording is worth reading in the original, because it is narrower than most people assume:

"Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8): (a) any economic operator to whom they have directly supplied a device; (b) any economic operator who has directly supplied them with a device; (c) any health institution or healthcare professional to which they have directly supplied a device."

Article 25(2) of Regulation (EU) 2017/745. It asks you to identify operators, not units. Whether that is enough for your own recall exposure is a separate question, and the answer is usually no.

Retention. Article 25(2) ties the retention period to Article 10(8): at least ten years after the last device covered by the declaration of conformity was placed on the market, and at least fifteen years for implantable devices.

Escalation and cooperation. If you believe a device does not conform, you do not make it available and you inform the manufacturer and, where applicable, the importer. When a manufacturer runs a field safety corrective action, you cooperate on it.

One caveat worth knowing: if you change a device's intended purpose, or relabel or repackage it beyond what Article 16 permits, you can take on manufacturer obligations. That happens more often than people expect in private-label and kitting arrangements.

Where this gets hard

Reading the obligations takes an hour. Meeting them takes longer. The legal minimum is a supply chain record, but a field safety notice is usually issued against a lot or a serial range. If your records stop at "we sold 40 units to this hospital group", the notice arrives and you still have to find out which 40 units, and whether they are still where you sent them.

That is why many importers and distributors keep records at device level even though the regulation does not require it everywhere. The regulation does not ask for it. It is what makes the regulation's question answerable in an afternoon instead of a week.

A practical order of work

1. Decide your role per product line, in writing. Importer, distributor, or manufacturer by reclassification. Many companies are two of the three at once, for different lines.
2. If you import anything and have no SRN, apply now. The mandatory date has passed.
3. Check each manufacturer you import from. You need their SRN and confirmation that their devices are registered, especially for anything they placed on the market before 28 May 2026.
4. Test your traceability with one real question. Pick a delivery from eighteen months ago. Ask your team who supplied it and who received it. Time how long the answer takes.
5. Decide how deep your records should go. The regulation sets the floor. Your recall exposure sets the level that is actually useful.

If you also sell into the United States, the separate piece on GUDID and EUDAMED covers how the two registries differ for the same device.

The part nobody budgets for

Registration is a one-time cost. Traceability is a standing one.

Every delivery from now on adds a record you may have to produce for ten or fifteen years. Teams that treat this as a 2026 project tend to find themselves in the same position two years later, because the process that created the gap never changed.

The companies that come out of this comfortably attached the record to the device rather than to a document. When each unit carries its own identity and history, "who did we ship this to" stops being a research task and becomes a lookup. The same setup usually pays for itself on the service side first, as in the case of a distributor that cut service costs by 27%.

If "which unit went where" takes your team more than a minute to answer, let us show you what device-level traceability looks like.