EUDAMED is a secure web-based portal acting as a central repository for information exchange between national Competent Authorities and the Commission in accordance with the MDR & IVDR Regulations. The intended purpose of EUDAMED is to compile and provide information for the manufacturing, distribution, certification and post-market surveillance of each device that falls within the MDR or IVDR. It is planned for the European Database for Medical Devices to be fully functional in May 2022.
What you need to know about each EUDAMED module?
EUDAMED is composed of 6 interconnected modules, which have a key role in the process:
- Actor registration (operational)
- UDI/ device registration (operational)
- Notified bodies and Certificates (operational)
- Vigilance (scheduled for May 2022)
- Market surveillance / Post-market surveillance (scheduled for May 2022)
- Clinical Investigations and performance studies (scheduled for May 2022)
Actor registration – registration of the different actors in the medical device field
The very first module “Actor Registration” is already operational since 1st December 2020. This module enables manufacturers to submit registration request and to access the EUDAMED. When the Actor registration requests is validated by an authorized representative or national competent authority for assessment, the economic operator* receives Single Registration Number (SRN), which is uniquely identified “the actor” in EUDAMED, official documents and reports, and means that the registration request is approved. Important note: if the economic operator has multiple roles, he has to request SRN for each actor role in separated registration requests.
*Manufacturer, Authorized representative, System & Procedure pack producer or Importer
UDI/ Device Registration – registration of medical devices
Part of the EUDAMED is the establishment of an electronic database for Unique Device Identification. This module contains information about devices` specifics, as the data is divided into two sections: UDI-DI and BASIC UDI-DI. The UDI-DI presents only product specifics and is also used as the ‘access key’ to the information stored in a UDI database. The Basic UDI-DI is the main key to EUDAMED and contains device-related information for a concreate product group, as well as it is referenced in the relevant documentation. Important note: several UDI-DIs can be generated for Basic UDI-DI, but a UDI-DI shall be associated with only one Basic UDI-DI. The UDI data must follow the EMDN nomenclature.
More about UDI regulation >> https://www.softgroup.eu/medical-devices-unique-device-identification-system-udi/
Notified bodies and Certificates – information on certificates issued by Notified Bodies
This module intends to enable the communication between the Notified Bodies and to provide information to the wide public about the Summaries of Safety and Clinical Performance (SSCP) and their assessment reports from Notified Bodies. The information on certificates such as QMS and certificates of conformity, their scope and validity period which are issued by Notified Bodies will be available.
Regard the risk classifications, the medical device’ manufacturer has to conduct a clinical assessment for all of their products. Through the electronic system, they could submit Periodic Safety Update Reports (PSUR), Periodic Summary Reports (PSR), as well as they could report incidents and provide information in the Field Safety Corrective Actions (FSCA), which will be distributed to the competent authorities, in the Field Safety Notices (FSN), which will be accessible in public. The provisions on the vigilance of the Medical Devices Directives are complemented by general guidelines on vigilance intended for harmonizing the process of implementation of the EU Directives on Medical Devices by manufacturers and competent authorities.
Market surveillance – coordination and cooperation between the member states
This module is intended to show publicly the summary of the results of market surveillance. The reports will be carried out by the Competent authorities, as the economic operator (subject of the report) will have the opportunity to give comments before the final report to be available.
Clinical Investigations and performance studies – management evaluation data
The submission of clinical/ performance studies and applications will give the opportunity for effective clinical evaluation and review. The systematic evaluating process is essential for the manufacturer‘s performance as for the end-user health and safety.
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SoftGroup does not guarantee the accuracy of any changes in the legislation and system that will be applied after the publishing date. Please consult SoftGroup’s experts before making business decisions.