The European Union Representative is the leading authority responsible for providing EU Registration Services to Non-European Medical Device Manufacturers. They specialize in offering support for Technical File development in compliance with the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).
Within medical devices, the European Union has established Notified Bodies, which play a crucial role in ensuring compliance with the MDR. These bodies are designated to assess the conformity of medical devices with regulatory requirements.
EUDAMED Registration is a proposed European Database and IT system introduced by the European Commission to meet the specific requirements outlined in the EU MDR 2017/745 and EU IVDR 2017/746 regulations. The primary objective of EUDAMED Registration is to enhance transparency for the public and healthcare professionals, facilitating the coordination of information related to medical devices and in-vitro diagnostic devices on the EU market.
EUDAMED consists of six interconnected modules and a public website. The modules are as follows: Actors Registration, UDI/Devices Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance and Post Market Surveillance, and Market Surveillance. The first module, Actors Registration, was expected to be available by December 2020, followed by the second and third modules, which are anticipated to be made accessible by May 2021.
To achieve EUDAMED Registration, manufacturers must compile the technical Documentation and appoint an Entity Authorized Representative (E.A.R) if necessary. The registration process applies to all risk classes of medical and in-vitro diagnostic devices. It should be completed before appointing a Notified Body for the conformity assessment procedure.
The first step in the process involves obtaining the Basic UDI-DI and UDIs from designated EU Commission entities such as IFA GmbH, GS1 AISBL, Health Industry Business Communications Council (HIBCC), or ICCBBA. Subsequently, economic operators, including manufacturers, EU Representatives, and importers, must register in the Actor Registration Module. After verification, the Competent Authority will issue a Single Registration Number (SRN) to the economic operators, which should be used when applying to the Notified Body for the conformity assessment.
The next step involves registering the devices in the UDI/Device Registration Module. Here, the basic UDI-DI obtained from the issuing entity is added, along with other relevant device and manufacturer information, such as quantity per package, manufacturer’s name and address, SRN, and member state information.
For low-risk medical devices and in-vitro diagnostic devices, the registration process is followed by preparing the EU Declaration of Conformity, as per the respective regulations, to proceed with the market launch. However, higher-risk devices require involvement from the Notified Body for the conformity assessment process.
Upon receiving audit approval for CE marking, manufacturers must prepare the EU Declaration of Conformity before initiating the market launch of their medical devices.