EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostics medical devices including the actor roles. With successful registration in EUDAMED, an actor or economic operator is granted a Single Registration Number Services (SRN).
Read hear how to correctly apply and read the SRN.
WHO NEEDS AN SRN?
Registration in the Actor Module of EUDAMED (module 1) is required for all economic operators or actors falling under the regulation 2017/745 (MDR) and/or 2017/746 (IVDR).
Registration, and thus a SRN, is mandatory for the following actors and roles:
- Manufacturer (or legal manufacturer)
- Authorized Representative (EC REP)
- System and procedure pack producer
- Importer
Distributors, however, have not to be registered in EUDAMED.
IS THERE MORE THAN ONE SRN?
Depending on the roles an actor or economic operator takes up, more than one SRN must be registered in EUDAMED.
As an example, an organization can have the roles of EC REP and Importer. Thus, the organization needs to register itself as EC REP and Importer and subsequently receives two SRNs.
- CH-AR-000000001 for the EC REP
- CH-IM-000000002 for the Importer
HOW IS THE PROCESS?
In the first step, each actor registers itself in EUDAMED. Second, the supervising and relevant CA will validate the data. Third, and if deemed acceptable, the Single Registration Number (SRN) is granted and emailed to the actor or economic operator.
HOW TO READ THE SRN?
The Single Registration Number (SRN) is make of three different parts. The first part is a two-letter country code (as per ISO2 country codes) for the actor, e.g. CH for Switzerland.
The second part is the two-letter abbreviation of the actor’s role, e.g. IM for Importer.
The third part is a 9-digit number code.
WHY SHOULD YOU CARE?
Under the MDR and IVDR, the actor registration in EUDAMED becomes a requirement. The SRN needs to be grant by the Competent Authority prior to the marketing of the product. Not complying with these requirements will most probably lead to the rejection or denial of market authorization.
HOW AVANTI EUROPE CAN HELP
Avanti Europe’s Experts have a decade-long track record and expertise in consulting and contracting to the Medical Device industry. Our experts support your company with hands-on workforce and support the notification and data entry into EUDAMED, definition of the QMS, the labeling of the product, processes, the documentation, training for the company staff, and audits for Medical Device QMS, and Supplier audits. Visit our online shop for checklists and other services.
A Single Registration Number is assign to all medical device legal Manufacturers, Authorized Representatives, System/Procedure Pack Producers and Importers involve in placing medical devices and IVDs on the European market. It is the primary means of identifying these so-called “Economic Operators” (EO) in the EUDAMED database. Manufacturers with multiple legal entities placing devices on the European market might have multiple SRNs.
To obtain an SRN, a request is submit via EUDAMED and then review by a national Competent Authority (Ministry of Health), who then issues the number. This portion of the EUDAMED database is call the “Actor Registration Module.” If a manufacturer is located outside of the European Union, their Authorized Representative will verify the registration request and then pass it along to the Competent Authority for review.