Applying for EUDAMED SRN Registration in the Netherlands

1. Overview

The Single Registration Number (SRN) is required for economic operators such as manufacturers, importers, and authorised representatives under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In the Netherlands, the CIBG assesses applications for SRN in the EUDAMED actors module. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

2. Who Needs to Apply

Manufacturers, importers, and authorised representatives must register in the EUDAMED actors module to obtain an SRN. This is mandated by Article 31 of Regulation (EU) 2017/745 (MDR) for medical devices and Article 28 of Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

3. Application Process

Step 1: Create EU Login

Create an EU login account at the European Commission website. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

Step 2: Log into EUDAMED

Log into EUDAMED and select the Dutch competent authority: Ministry of Health, Welfare and Sport and Health and Youth Care Inspectorate (NL-CA-058 under Competent Authority). Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

Step 3: Select Request Type

• Actor registration: For organisations without an SRN; appoint a local user administrator (LUA) to validate user requests and manage accounts.
• Access request: For organisations with an existing SRN to grant access to additional individuals; handled by the LUA. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

Step 4: Enter Details

In Step 1 of actor registration, enter the number in the national Commercial Register. In Step 2, enter the address details linked to the national Commercial Register. The CIBG assesses applications for uniqueness, completeness, and Dutch base; upon approval, an SRN is assigned. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

4. Required Information and Documents

• EU login account.
• Number in the national Commercial Register.
• Address details linked to the national Commercial Register.
• Appointment of a LUA for actor registration. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

5. Costs

There are no costs associated with applying for an SRN. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

6. Processing Time

Applications are processed within 15 days. If not processed within this time, contact CIBG at medische_hulpmiddelen@minvws.nl. For amendments, contact the EUDAMED help desk at SANTE-EUDAMED-SUPPORT@ec.europa.eu. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

7. Transitional Provisions and Related Regulations

The SRN grants access for requesting conformity assessments, providing product information, and submitting reports on incidents or corrective actions. No specific transitional provisions are detailed on the page, but the rules introduce obligations under MDR and IVDR for recording information in EUDAMED. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

8. Additional Notes

CIBG is the competent authority in the Netherlands for registration. For more information, refer to the EUDAMED User Guide for Economic Operators, the EUDAMED page, and the Ministry of Health, Welfare and Sport website. Monitor the website for future developments. Source: https://english.farmatec.nl/medical-devices/applying-for-a-eudamed-srn-registration-number

9. Conclusion

Obtaining an SRN is essential for compliance with EU medical device regulations, enabling proper registration and market access in the Netherlands.