What is EUDAMED
The EUDAMED stands for “European Database for Medical Devices” is operated by the European Commission and serves to centralize all relevant information on medical devices and to ensure traceability.
EUDAMED is based on a decision of the European Commission (2010/227 / EU). In this decision, the EU formulates the purpose of Eudamed:
“The European Medical Devices Database aims to improve market surveillance by giving competent authorities swift access to information about manufacturers and their authorized representatives, products and certificates, and vigilance data; it should also contribute to the exchange of information on clinical examination data and the consistent application of the above directives, in particular with regard to reporting requirements.”
The example of the PIP scandal (ban on breast implants from a French manufacturer) shows that centralized management of data such as clinical trials, market surveillance and recall can make sense and save lives.
What is stored in the EUDAMED
The EUDAMED will comprise a total of 6 areas, all of which will be electronically accessible to the medical device manufacturer.
That All information can be transmitted fully electronically.
The 6 pillars of EUDAMED consist of:
• Module ACT – Actor Registration
This module allows manufacturers (actors) to register and later be clearly identified. The actors include manufacturers, importers and EU representatives.
After registration and verification of the data provided, the actors will have access to EUDAMED. With the help of the SRN (Single Registration Number) every economic actor can be clearly identified.
• Modul UDI – Unique Device Identification
The UDI module will contain all device-specific information and have the same functions as the comparable database of the American Health Authority (FDA) of GUDID. The main difference to the GUDID is that the UDI data is divided into the area BASIC UDI-DI and the UDI-DI. The BASIC UDI-DI serves to map all common properties of a product group. The UDI-DI contains only the product-specific information. There can be several UDI DIs for a BASIC UDI DI. Conversely, a UDI DI is assigned to exactly one BASIC UDI DI. (See picture below)
As an economic operator, you are responsible for managing all UDI attributes in your own company and transferring the data to EUDAMED. Read here how we can support you.
• Module CRF – Certificate
Any medical device distributed in Europe will require a valid approval certificate in the future in accordance with MDR 2017/745 and IVDR 2017/746. This certificate certifies that the product meets all the regulatory requirements of a medical device.
By grouping a product group into a BASIC UDI DI, you simply need a certificate for one product group instead of each article within a product group. These certificates will be managed in the module CRF in the future.
• Module CIPS – Clinical Investigation
According to the new Medical Devices Directive (MDR), manufacturers of medical devices are required to conduct a clinical assessment for all their products, regardless of the risk class, including post-market clinical follow-up (PMCF) ,
The clinical evaluation is an essential manufacturing task and an integral part of a manufacturer’s quality management system (Article 10, paragraphs 3 and 9f MDR).
By definition, clinical evaluation is a systematic and planned process for the continuous generation, collection, analysis and evaluation of clinical data on a product. The clinical review will verify the manufacturer’s safety and performance, including clinical benefit.
• Module VGL – Vigilance
Any serious incident involving medical devices must be documented and provided. In the technical documentation, the number of incidents and objects must be reported.
Safeguard measures on the products made available on the Union market must also be reported.
• Module MSU – Market Surveillance
In the module MSU the results of the market surveillance are reported back. The competent authorities are those who carry out market surveillance and publish the reports.
The competent authority which has carried out the inspection shall inform the economic operator which was the subject of the inspection of the contents of the report referred to in paragraph 6 of this Article. Before accepting the report, the competent authority will give this economic operator the opportunity to comment. This final control report shall be recorded in the electronic system referred to in Article 100 (module MSU).