Single Registration Number (SRN)
What is a Single Registration Number (SRN)?
A Single Registration Number (SRN) is a unique identifier assigned to economic operators — including manufacturers, EU Authorised Representatives, and importers — upon registration in the EUDAMED database. Under Regulation (EU) 2017/745 (EU MDR) and Regulation (EU) 2017/746 (IVDR), an SRN is required before a medical device or in vitro diagnostic device can be lawfully placed on the EU market.
Why It Matters
The SRN is the gateway to EU market access for medical device economic operators. Without a valid SRN, a manufacturer cannot complete device registration in EUDAMED, and a device cannot lawfully be placed on the EU market. It is also a prerequisite for obtaining a CE mark under the EU MDR and IVDR conformity assessment process.
For non-EU manufacturers, the SRN registration process must be initiated by or coordinated with their EU Authorised Representative, who must themselves hold a valid SRN. Errors or delays in obtaining an SRN can hold up the entire market access process.
For medical device manufacturers and their EU Authorised Representatives, obtaining and maintaining a valid SRN is one of the first and most fundamental steps in EU regulatory compliance.
Key Requirements
Who Needs an SRN?
An SRN is required for the following economic operators before placing devices on the EU market:
- Manufacturers of medical devices or IVDs established in the EU
- EU Authorised Representatives acting on behalf of non-EU manufacturers
- Importers of medical devices into the EU market
This requirement applies under:
- Regulation (EU) 2017/745 – Medical Device Regulation (EU MDR)
- Regulation (EU) 2017/746 – In Vitro Diagnostic Regulation (IVDR)
Each economic operator receives a single SRN regardless of how many devices they manufacture or represent. The SRN is linked to the operator’s registration in EUDAMED and must be kept accurate and up to date.
Responsibilities Relating to the SRN
While specific obligations depend on the role in the supply chain, responsibilities commonly include:
- Registering as an economic operator in EUDAMED to obtain an SRN prior to placing devices on the market
- Ensuring the SRN is included on device labels or packaging where required under the regulation
- Keeping registration information accurate and notifying EUDAMED of any changes within one week
- Linking the SRN to individual device registrations and UDI records in EUDAMED
- Ensuring the EU Authorised Representative’s SRN is correctly associated with the manufacturer’s registration
SRN and the EU Authorised Representative
For non-EU manufacturers, the EU Authorised Representative must hold their own SRN and be registered in EUDAMED before the manufacturer can complete their own registration. The Authorised Representative’s SRN is linked to all devices they represent, providing competent authorities with a clear and accessible point of contact for every device on the EU market.
In practice, many non-EU manufacturers rely on their Authorised Representative to initiate and manage the EUDAMED registration process, including obtaining and maintaining the SRN.
Need Medical & IVD Device Compliance support for the EU and UK?
Euverify provides end-to-end EU MDR and UK regulatory compliance for medical device and IVD manufacturers — including EU Authorised Representative, EUDAMED, HPRA, and MHRA registration. Our team supports technical documentation review, regulatory communication, and ongoing compliance management across both markets.
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