One of the provisions of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is to have medical devices and in vitro diagnostic devices registered in the European database for medical devices (EUDAMED).
The registration is essential in tracing the life cycle of the MDs and IVDs distributed in European Union (EU) countries.
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What Is EUDAMED?
EUDAMED is a collaborative database or IT system that is partially accessible to the public. Manufacturers or importers of MDs and IVDs to be sold and used within the EU must register their products to the system for transparency and traceability.
This system is crucial for monitoring the safety and performance of a device. Once fully operational, EUDAMED will be interoperable and will have a notification system for manufacturers, importers, and distributors, as well as a dissemination system for the public.
For now, EUDAMED registration is not mandatory because the system has not been completely set up. The elements that are currently accessible can be used voluntarily. For now, the projected date of mandatory compliance is Q2 2026, which is 24 months after all six EUDAMED modules are officially released.
EUDAMED Modules
Actor Registration
The Actor Registration module has been available since Dec. 1, 2020. Economic operators—manufacturers, authorized representatives, importers and distributors—can voluntarily register under this module to obtain an actor identifier or single registration number (SRN).
Here are the simple steps for registration:
- Select your role: manufacturer, authorized representative, importer, system/procedure pack producer
- Select your country
- Enter your registered trade name
- Enter the requested information about your organization
- Download, fill out, and sign the Declaration on Information
- Upload registration form
The registration will be forwarded to the National Competent Authority of the country where you are doing business. The registration will be reviewed, and you will be asked to pay the registration fee and send the receipt to the authority.
General Validation Process to Get an SRN
SRNs are for manufacturing, authorized representatives, and importers of MDs and IVDs. The purpose of SRNs is to establish a unique identity for every economic operator in the EUDAMED.
Here are the steps in the validation process to get an SRN:
- The economic operator requests an actor registration from EUDAMED.
- Authorized representatives will verify the registration request of non-EU manufacturers and pass it on to the national competent authority for assessment.
- The authority will issue the actor ID or SRN.
UDI Database and Registration of Devices
The unique device identifier (UDI) is a series of alphanumeric characters that will serve as the device’s tracking ID. The UDI database is the registry of all MDs and IVDs within the EU market.
The UDI is a requirement in packaging MDs and IVDs. However, the use of the UDI Database and Registration of Devices module, while already available, is not yet mandatory.
There are four issuing agencies that provide UDIs: GS1 Global Office, Health Industry Business Communications Council, International Council for Commonality in Blood Banking Automation, and Informationsstelle für Arzneispezialitäten or IFA.
Notified Bodies and Certificates
The Notified Bodies and Certificates module is the third and final available module that economic operators can use voluntarily.
A notified body is an organization designated to ensure that devices are safe and environmentally sound before they are released in the EU market. It is also tasked with registering any information about the following certificates in the EUDAMED:
- New certificates
- Amendments and supplements to certificates
- Suspended certificates
- Reinstated certificates
- Withdrawal of certificates
- Refusal or restrictions on certificates
Other Modules
The following modules are not yet available—the full EUDAMED system is expected to be released in Q2 2024:
● Clinical Investigation and Performance Studies module – creates a single identification for clinical investigations.
● Vigilance and Post-Market Surveillance module – monitors the safety and performance of products on the market.
● Market Surveillance module – traces unsafe devices that should be withdrawn from the market.
Importer registration
It is recommended your importer is officially registered with the competent authority and has an SRN number. With this SRN Number the medical devices logistics can add the manufacturer and product groups so the importer of record for each product group is officially registered and can be tracked.
Should You Register in EUDAMED?
Registration in the EU database is not yet required, but manufacturers, authorized representatives, importers, and distributors can voluntarily enroll in the actor registration and UDI and devices registration.
While not mandatory, EUDAMED registration will help economic operators transition easily once the system becomes fully operational. Registration will make tracing MDs and IVDs simple in case performance and quality issues arise.
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