EUDAMED Actor Registration and the SRN: Your Complete Guide to SRN Requirements for 2026 

Every conversation about EUDAMED eventually reaches UDI data, device submissions, and certificate linkages. But there is a step that comes before all of that, one that is overlooked often enough to cause real delays.  Before any compliance action moves forward, a company must be recognized within the system. 

That is what Actor Registration is for. It is the foundation of EUDAMED, and without it, none of the other modules are accessible. 

With mandatory use confirmed from May 28, 2026, getting Actor Registration right and done early, is essential. This guide explains exactly what it involves, who it applies to, and what the process looks like from start to finish. 

EUDAMED Actor Registration: Roles and requirements explained 

In EUDAMED, an actor is any natural or legal person with a specific role in the medical device supply chain that requires registration in the system. For economic operators, this includes manufacturers (EU and non-EU), authorized representatives, importers, and system and procedure pack producers. 

One of the most common misconceptions is that distributors are also required to register. They are not. Distributors have no actor role in EUDAMED and will not receive an SRN. If your supply chain teams are expecting to see your distributor network reflected in the system, that expectation needs to be corrected early. 

Another area where companies often get tripped up is custom-made devices. Most custom-made device manufacturers are exempt from Actor Registration. The exceptions are Class III custom-made implantable devices, where notified body certification creates an indirect registration requirement. Custom-made device manufacturers that need to submit vigilance data must also register. 

If your company needs to report a serious incident, you will need to register in the Actor module to access the Vigilance module when it becomes mandatory. 

EUDAMED SRN (Single Registration Number) explained: What it is and how it works 

Once Actor Registration is approved by the relevant competent authority (CA), EUDAMED generates a Single Registration Number (SRN). This is a unique, EU-wide identifier for the economic operator. It is permanent, role-specific, and publicly visible in the EUDAMED database. 

The SRN consists of 13 alphanumeric characters: a two-letter ISO country code, an actor type abbreviation, and a nine-digit number.  

An important detail: the SRN is role-specific, not company-specific. If your organization operates as both a manufacturer and an importer, you must register separately for each role and will receive a separate SRN for each. A company that is a manufacturer, authorized representative, and importer must submit three separate registration requests and will manage three distinct SRNs. 

System and procedure pack producers receive what is technically called an Actor ID rather than an SRN. In practice, both identifiers look identical and serve the same purpose. 

EUDAMED’s two-tier structure: Economic operators and supervising entities 

EUDAMED is built around two distinct groups: economic operators who must register to place devices on the market, and supervising entities who validate, monitor, and manage the system. 

Economic Operators are the companies and organizations that handle medical devices throughout the supply chain: 

• Manufacturers place devices on the EU market under their own name or trademark. They register UDIs and receive an SRN directly. 
• Authorized Representatives act on behalf of non-EU manufacturers. They verify that the manufacturer has registered their UDIs in EUDAMED before receiving an SRN. 
• Importers place devices from third countries on the EU market. They verify CE marking and UDI registration before receiving an SRN. 
• Systems and procedure pack producers (SPPPs) combine CE-marked medical devices. They must register in the Actor module but receive what is technically called an Actor ID rather than an SRN (though both look identical). 

Supervising Entities are the regulatory bodies that operate and oversee EUDAMED: 

• European Commission develops and operates EUDAMED, and defines actor roles and system rules. 
• Competent Authorities (CAs) are national regulators that validate actor registrations. When an economic operator submits an Actor Registration request, the relevant CA reviews and approves it before the SRN is issued. 
• Notified Bodies are designated conformity assessment organizations that upload and manage certificates in EUDAMED. They verify that manufacturers have registered their devices before completing the certificate upload in EUDAMED 
• Designating Authorities are the bodies that designate and monitor Notified Bodies within their jurisdiction. 

This structure clarifies who registers for an SRN (economic operators) and who validates those registrations (supervising entities). Understanding this distinction helps explain the approval process and where potential delays may occur.

Where to use your EUDAMED SRN: Regulatory requirements and documents

Once issued, the SRN becomes a required identifier across your entire regulatory footprint. From the moment you receive your SRN, under MDR Article 31 and IVDR Article 28 it must appear in:  

• Declarations of Conformity for MDR/IVDR CE-marked devices (DoC) 
• Applications to notified bodies for conformity assessment 
• Summaries of safety and clinical performance (SSCP) 
• Certificates issued by notified bodies 
• Serious incident reports and FSCAs once the Vigilance module becomes mandatory 

Registration is not a one-time task. If any information changes (company name, registered address, etc.) it must be updated in EUDAMED within one week. This is a live compliance obligation for the lifetime of your registration, not something that can be revisited quarterly. 

Actor Registration is also the prerequisite that activates UDI and device data submissions. Until your SRN is in place, no device data can flow into EUDAMED. That dependency makes Actor Registration the item that determines how much time you have for everything else. Companies must complete Actor Registration before the May 28, 2026 deadline for new devices and before the November 27, 2026 deadline for devices already on the market. 

EUDAMED Actor Registration timeline: Why early registration is critical

As the May 2026 deadline draws closer, competent authorities across EU member states are handling a growing volume of registration requests. The review timelines that were measured in days earlier in the process are already stretching.  

The osapiens HUB for Medical Devices supports manufacturers and economic operators through every stage of medical device compliance and EUDAMED readiness: from Actor Registration through UDI/device data submission, ongoing data quality management, and integration with global regulatory databases. If you are assessing your current readiness, our team can help you understand where you stand and what to prioritize.