EUDAMED Actor Registration and the Single Registration Number (SRN)

Economic operators involved in the supply and distribution of medical devices within the European Union must understand and comply with EUDAMED actor registration requirements. This process is fundamental to ensuring traceability and regulatory oversight under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). Registration is a prerequisite for many subsequent activities within the EUDAMED database.

#Obligation to Register as an Economic Operator

The MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) mandate the registration of specific economic operators in EUDAMED. This ensures that all key entities in the medical device supply chain are identifiable and accountable. The primary economic operators required to register are:

• Manufacturers: As defined in Article 2(12) MDR and Article 2(11) IVDR.
• Authorised Representatives: As defined in Article 2(13) MDR and Article 2(12) IVDR.
• Importers: As defined in Article 2(14) MDR and Article 2(13) IVDR. Importers have specific obligations, including verifying device registration before placing devices on the market, as per Article 13(2)(c) MDR and Article 12(2)(c) IVDR.
• Producers of systems and procedure packs: As defined in Article 22(1) MDR. These operators must register if they are not already a manufacturer.

Distributors, as defined in Article 2(15) MDR and Article 2(14) IVDR, generally do not register themselves directly as 'actors' in EUDAMED. Instead, their role is addressed through other mechanisms, such as traceability via UDI. However, some Member States may require distributors to register nationally or impose specific EUDAMED-related obligations on them. Distributors are advised to consult their national competent authority for clarity on any specific national requirements.

#The Single Registration Number (SRN)

Upon successful completion of the actor registration process in EUDAMED, the economic operator is assigned a Single Registration Number (SRN). This SRN is a unique identifier for that specific economic operator across the entire European Union. The SRN is crucial for regulatory compliance and transparency.

#Use of the SRN

The SRN serves several critical functions:

• Identification: It uniquely identifies the economic operator in all EUDAMED modules and official communications related to the MDR and IVDR.
• Device Registration: Manufacturers and authorised representatives must use their SRN when registering devices in EUDAMED, as specified in Article 29(2) MDR and Article 26(2) IVDR. Importers also rely on the manufacturer's or authorised representative's SRN to confirm device registration status.
• Certificate Linkage: Notified Bodies include the manufacturer's SRN on certificates of conformity issued under the MDR and IVDR.
• Incident Reporting: Economic operators involved in vigilance activities use their SRN when submitting incident reports or Field Safety Corrective Actions (FSCA) in EUDAMED, as outlined in Article 87 MDR and Article 82 IVDR for manufacturers, and Article 14(4) MDR and Article 13(4) IVDR for importers and distributors.
• Post-Market Surveillance: The SRN links Post-Market Surveillance (PMS) data to the responsible economic operator.
• Economic Operator Information Module: The SRN is visible in the EUDAMED public interface, allowing stakeholders to verify the identity and status of registered economic operators.

#Who is registered by whom, and who does what?

#Registration Process and Current Status

The actor registration module of EUDAMED has been available since December 2020. Economic operators are strongly encouraged to register promptly. The registration process involves submitting an application to the relevant national competent authority. The competent authority validates the information provided and, upon approval, assigns the SRN.

It is important to note that while the actor registration module is functional, the full mandatory use of EUDAMED is being phased in. The European Commission has provided a roadmap for the staggered implementation of EUDAMED modules. Economic operators should regularly consult the European Commission's official EUDAMED website and their national competent authority for the most current information regarding mandatory dates and scope. For instance, some Member States have already made registration mandatory under national law, irrespective of the full EUDAMED mandatory date.

#Common mistakes in practice

• Delaying Registration: Not initiating actor registration promptly, leading to potential delays in placing devices on the market or meeting other regulatory deadlines.
• Incorrect Role Selection: Registering under an incorrect economic operator role (e.g., a distributor attempting to register as an importer when their activities do not align with Article 2(14) MDR or Article 2(13) IVDR).
• Incomplete Information: Submitting incomplete or inaccurate data during the registration process, causing delays due to requests for clarification from the competent authority.
• Missing Documentation: Failing to provide all required supporting documents, such as mandates for authorised representatives or proof of establishment.
• Ignoring National Requirements: Overlooking specific national competent authority requirements or deadlines for actor registration that may precede the full EUDAMED mandatory dates.
• Misunderstanding SRN Use: Not understanding where and when the SRN must be used, leading to non-compliance in subsequent EUDAMED activities like device registration or incident reporting.
• Assuming Distributor Exemption: Distributors assuming they have no EUDAMED responsibilities at all, despite their obligations under Article 14 MDR and Article 13 IVDR to verify certain device information and cooperate with competent authorities.

#EUdaMed AI and Your Compliance

Understanding and navigating EUDAMED actor registration is a foundational step in regulatory compliance. While EUdaMed AI provides support for various EUDAMED requirements, including registering devices already on the market in EUDAMED by 27 November 2026 and helping with legacy device registration in EUDAMED: importer and distributor duties, the ultimate responsibility for accurate actor registration and ongoing compliance remains with the economic operator. The platform can assist in streamlining data management and submission processes, but it does not replace the dedicated Person Responsible for Regulatory Compliance. Explore how the platform can streamline your EUDAMED operations: https://eudamedai.com/#platforma. For further insights into the broader impact of EUDAMED, refer to what changes for distributors and importers now that EUDAMED modules are mandatory.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.