From 28 May 2026, EUDAMED registration becomes an operational obligation for every manufacturer placing medical devices and in vitro diagnostic medical devices on the European market. It is no longer a step that can be postponed: anyone who manufactures, assembles, or distributes devices needs to get organised now, because the deadlines are close and the data required is extensive. In parallel, Switzerland is also activating its own national database, on its own timeline. In this article you’ll find what is changing, by when, and how to handle it all without being caught out by the deadline.
What is EUDAMED, and why does it become mandatory on 28 May 2026?
EUDAMED is the European database for medical devices: a centralised system where manufacturers register, devices are recorded before being placed on the market, Notified Bodies upload certificate data, and Authorities oversee safety and compliance.
From 28 May 2026, the use of the fully operational modules becomes mandatory. From that date, every manufacturer introducing new medical devices or IVDs onto the EU market must use the modules required to register operators and products. In practice: no EUDAMED, no market access.
Which EUDAMED modules are mandatory for manufacturers?
For manufacturers, the obligations centre on two modules:
- Actor Registration module (ACT) — registration of economic operators. It assigns each operator a Single Registration Number (SRN), the unique identifier without which it is impossible to proceed (legal basis: Art. 30 MDR and Art. 27 IVDR).
- UDI & Device Registration module — registration of devices and their UDI identifiers (legal basis: Art. 28-29 MDR and Art. 25-26 IVDR).
The other two operational modules — Notified Bodies and Certificates (NB/CRF) and Market Surveillance (MSU) — do not concern manufacturers, but rather Notified Bodies and Competent Authorities respectively.
The entire technical framework of the data to be submitted rests on Annex VI of Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746: the articles set the legal obligation, while Annex VI defines the operational detail.
What EUDAMED deadlines do you need to meet?
There are two dates to mark in your calendar, with one important exception:
- 28 May 2026 — registration obligation for new devices placed on the market from this date.
- 27 November 2026 — deadline for registering devices already on the market, including legacy devices, before 28 May 2026.
- Watch out for the exception: the extension to November does not apply to devices subject to vigilance actions, incidents, or field safety corrective actions (FSCA/ASCA). In these cases, it is strongly recommended to act without waiting.
How does registration work: SRN, Basic UDI-DI, and the data hierarchy?
The process follows a precise order.
Operator first, then product. Obtaining the SRN through the ACT module is the preliminary step: without a number validated by the Competent Authority, you cannot register products or interact with the Notified Body. Access management can be structured across multiple profiles — the Local Actor Administrator (LAA) authorises the Local User Administrators (LUA), who request access using their own EU Login account.
The Basic UDI-DI is the cornerstone. It represents the identifier for the group of devices sharing the same intended purpose, class, and essential characteristics (Annex VI, Part C). It must be registered by the manufacturer before the Notified Body can upload the certificates, and it can be entered even if certification is not yet complete.
The data set must be populated carefully. For each device you enter attributes such as risk class, intended purpose, and technical characteristics (Annex VI, Part B), in the languages required by the system and consistent with the technical documentation.
Traceability must be complete. Every level of packaging and every variant (UDI-DI) must be recorded. For legacy devices, the system allows the old identifier to be linked to the new compliant code.
One often-underestimated point: consistency between the data in EUDAMED and what appears on labelling and instructions for use (IFU) is the manufacturer’s sole responsibility.
Is registration in the National Database still mandatory?
No. With EUDAMED now fully operational, registering devices in the National Database becomes optional. It remains, however, a choice to weigh on a case-by-case basis, depending on the product’s characteristics and distribution channels: in some situations, voluntary registration still makes sense. This is exactly the kind of assessment worth making with an experienced partner before deciding.
Swissdamed: what changes for those selling in Switzerland?
Anyone also selling in Switzerland has to manage a second track. Following the non-renewal of the Mutual Recognition Agreement (MRA) with the EU, Switzerland has taken an independent regulatory path: Swissdamed is the Swiss equivalent of EUDAMED, but it is a separate platform, with its own rules.
The dates to know:
- 1 July 2026 — UDI code registration on Swissdamed, currently optional, becomes mandatory for all devices placed on the Swiss market.
- 31 December 2026 — end of the transitional period.
- No transitional period for devices involved in serious incidents, field safety corrective actions (FSCA), or adverse-event trends: for these, the obligation applies from 1 July 2026.
Compatibility with EUDAMED-compliant XML files reduces the workload, but does not eliminate the dual management. Non-Swiss manufacturers operate through a CH-REP (Swiss authorised representative), which adds administrative burden compared with the EU market alone.
How do you turn compliance into a strategy?
The key is not to treat EUDAMED and Swissdamed as two isolated deadlines, but to integrate them into a single compliance plan. Those producing broad catalogues, with many codes and multiple target markets, need:
- an orderly inventory of operators, Basic UDI-DIs, and packaging hierarchies;
- technical documentation that is consistent with the uploaded data and with labels and IFUs;
- periodic data maintenance (operators must confirm its accuracy at regular intervals);
- a combined EU-Switzerland view, to avoid duplicating work unnecessarily.
FAR.Medical supports companies in the medical sector with the preparation and maintenance of Technical Documentation compliant with Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), in support of device registration obligations across the databases. Our team helps you set up data and documents in good time, so you reach the deadlines with an orderly process rather than a last-minute rush.
Frequently asked questions about EUDAMED and Swissdamed
When does EUDAMED become mandatory? From 28 May 2026 for new devices. Devices already on the market, including legacy devices, must be registered by 27 November 2026 (except for those subject to vigilance, where it is best to act right away).
Can you register the Basic UDI-DI before you have the certificate? Yes. The system allows registration even during the conformity assessment process.
Is registration in the National Database still required? It is optional. Whether it is worthwhile should be assessed based on the product and its sales channels.
I also sell in Switzerland — what do I need to do? You need to manage Swissdamed in parallel with EUDAMED. UDI registration on Swissdamed becomes mandatory from 1 July 2026, with a transitional period until 31 December 2026; non-Swiss manufacturers operate through a CH-REP.
Want to understand how to set up the registration of your devices in EUDAMED and Swissdamed without weighing down your processes? Get in touch with the FAR.Medical team: together we’ll review technical documentation, UDI codes, and the timelines for your catalogue.