5-Step Guide to Obtaining Single Registration Number (SRN)

Single Registration Number (SRN) under the EU MDR is a unique identifier assigned to economic operators. The SRN is assigned once the economic operators are registered in the EUDAMED database. It serves as a critical regulatory tool for ensuring traceability, transparency, and accountability across the EU medical device market. Issued by national competent authorities, the SRN is required for accessing EUDAMED modules and submitting device information. Additionally, it is required for fulfilling legal obligations, such as declarations of conformity and vigilance reporting. Notably, each SRN is role-specific. Hence, organizations acting in multiple roles must obtain separate SRNs for each role. Therefore, SRN is foundational for regulatory compliance and market access. In this blog, we will discuss what is single registration number and its purpose. Additionally, we will provide a step-by-step guide to securing SRN along with pro tips. Furthermore, we have highlighted the significance and importance of SRN.

What is single registration number (SRN)?

Single registration number (SRN) is a unique alphanumeric code issued by a national competent authority via the EUDAMED database. SRN is essential for accessing EUDAMED and fulfilling legal obligations. It is used to identify economic operators involved in placing medical devices or IVDs on the EU market. By linking devices to responsible economic operators, SRN plays a vital role in traceability. Moreover, SRN enables regulators and stakeholders to verify who is placing devices on the market. Furthermore, SRN is a key reference during inspections and conformity assessments. Therefore, SRN plays a crucial role in ensuring traceability, transparency, and accountability of medical devices in the EU market.

Who needs an SRN?

The following economic operators require an SRN:

• Legal Manufacturers (EU and non-EU)
• Authorized Representatives (for non-EU manufacturers)
• Importers (bringing devices into the EU)

Note: Distributors do not receive SRNs, as they are not required to register in EUDAMED

Primary purposes of the SRN

• Unique identification: The single registration number serves as an EU-wide unique identifier for economic operators, namely manufacturers, authorized representatives, and importers, registered under MDR.
• EUDAMED access: It is the gateway to using EUDAMED modules, including UDI/device registration, vigilance, and clinical investigation reporting.
• Regulatory traceability: SRN links each device to its responsible actor, enabling regulators to trace accountability across the supply chain.

Key considerations for SRN

• Multiple roles require multiple SRNs: If your organization acts in more than one role (e.g., manufacturer and importer), you must register separately for each and secure a single registration number for each role.
• Non-EU manufacturers: Must appoint an authorized representative (AR) in the EU before registration. The AR registers first and provides the SRN to the non-EU manufacturer.
• SRN use cases: SRN is required for declaration of conformity, technical documentation, vigilance reporting, and notified body certificates.

Step-by-Step guide to obtaining single registration number

Obtaining a single registration number (SRN) under the EU MDR is a structured process involving registration in the EUDAMED database. We have provided a detailed step-by-step breakdown of the process of obtaining SRN.

Step 1: Prepare your actor profile

Before initiating registration, collate the following information:

• Legal entity information: Name, address, VAT number, and contact details.
• Role(s): Specify whether you are registering as a manufacturer, authorized representative, importer, etc.
• Person responsible for regulatory compliance (PRRC): Name, contact details, and qualifications (required for manufacturers and authorized representatives).
• Supporting documents: Business registration certificate, mandate (for ARs), and other role-specific documents.

Step 2: Access the EUDAMED actor registration module

• Visit the EUDAMED public website and navigate to the actor registration section.
• Use EU Login (European Commission Authentication Service) to access the system. If you do not have an EU Login, you must create one.

Step 3: Submit the actor registration request

• Fill out the Actor Registration Form in EUDAMED.
• Upload required documents (e.g., mandate for ARs, proof of establishment).
• Assign a Local Actor Administrator(LAA). This person will manage your organization’s EUDAMED access.

Step 4: Validation by national competent authority (NCA)

• The registration request is routed to the NCA of the Member State where the economic operator is based.
• The NCA reviews the submission and may request clarifications or additional documents.
• Once satisfied, the NCA approves the registration.

Step 5: Issuance of the SRN

• Upon approval, EUDAMED automatically generates and assigns a single registration number (SRN).
• The SRN is unique to the actor and role (e.g., a company acting as both manufacturer and importer must register separately for each role and receive separate SRNs).
• The SRN is visible in your EUDAMED actor profile and must be used in all regulatory documentation and communications.

What is the strategic importance of SRN?

We have presented the significance and importance of SRN.

1. Market access: Without an SRN, economic operators cannot register devices in EUDAMED, which is mandatory for placing products on the EU market. SRN is referenced in Declarations of Conformity, Notified Body certificates, and technical documentation.
2. Transparency and public trust: SRNs are published on the EUDAMED public website, allowing stakeholders to verify the legitimacy of economic operators. SRN enhances visibility of who is responsible for each device, especially critical in post-market surveillance and vigilance.
3. Audit and inspection readiness: Single registration number is a key reference during competent authority audits, Notified Body assessments, and market surveillance activities. Additionally, it facilitates quick identification and validation of regulatory roles and responsibilities.
4. Multi-role and multi-entity management: Companies acting in multiple roles (e.g., manufacturer and importer) must obtain distinct SRNs for each role. It supports complex organizational structures and cross-border operations by clearly delineating responsibilities.
5. Digital harmonization: SRN is foundational to digital-first regulatory systems, enabling automated data exchange, dashboarding, and compliance tracking. Furthermore, SRN aligns with EU’s vision for interoperable, transparent, and efficient medical device regulation.

8 Pro tips for easily obtaining SRN

1. Pre-validate legal entity details: Ensure your company’s legal name, address, VAT number, and contact details match official records. Discrepancies can delay validation by the Competent Authority (CA).
2. Prepare role-specific documentation in advance: For authorized representatives, have a signed mandate from the non-EU manufacturer. For manufacturers/importers, include business registration certificates and PRRC credentials. Use a document checklist to avoid back-and-forth with the CA.
3. Assign a competent local actor administrator (LAA): Choose someone with regulatory knowledge and EU Login access. The LAA manages your organization’s EUDAMED access and user roles, which is critical for future updates.
4. Use a role-based registration strategy: If your organization has multiple roles (e.g., manufacturer + importer), register each role separately. Maintain a centralized SRN tracker to manage multiple SRNs across entities and roles.
5. Engage early with the national competent authority: Some NCAs offer pre-submission guidance or templates. Proactively check any country-specific nuances (e.g., language, document format).
6. Build a digital dashboard: Track single registration number status, actor roles, submission dates, and CA feedback. Integrate with your QMS or regulatory information management system (RIMS) for audit readiness.
7. Embed SRNs in regulatory templates: Pre-fill SRNs into your declaration of conformity, technical documentation headers, and vigilance forms. This ensures consistency and speeds up downstream submissions.
8. Test with one entity first: Test the process with a single legal entity to identify bottlenecks. Use lessons learned to scale across affiliates or business units.

Therefore, the single registration number (SRN) is a cornerstone of regulatory transparency and operational efficiency under the EU MDR and IVDR frameworks. It uniquely identifies each economic operator and their associated role within the EUDAMED ecosystem. SRN enables seamless device traceability, streamlined communication with authorities, and audit-ready documentation. As the EU continues to digitize and harmonize medical device oversight, securing and strategically managing SRNs are a vital regulatory compliance requirement. Moreover, SRN is a proactive step towards building a resilient and future-proof regulatory infrastructure.