Leading EU Representative for Medical Device providing EU Registration Service for Non European Medical Device Manufactures
EUDAMED Registration is a European Database an IT system proposed by the European Commission for medical devices and in-vitro diagnostic devices to meet certain requirements mentioned in regulations EU MDR 2017/745 and EU IVDR 2017/746, respectively.
EUDAMED registration will enhance the transparency for the public and healthcare professionals and coordination of information regarding medical devices and IVDs on the EU market. As per the information on the EU website, the EUDAMED is structured around 6 interconnected modules and a public website:
- Actors Registration
- UDI/Devices Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post Market Surveillance
- Market Surveillance
It is known from the EU website that the Actors Registration (first module) will be available first and its deployment is expected by December 2020 and, the second and the third modules are expected to be made available by May 2021.
Steps towards achieving EUDAMED Registration
Soon after the technical documentation has compiled, and has appointed the E.A.R, if required, the manufacturer may start the EUDAMED Registration processes.
This process is applicable to all the risk classes of Medical Devices and IVDs. Note that this process should be done prior to appointing the Notified Body for the assessment of the conformity assessment procedure, as applicable.
Step I – Basic UDI-DI and UDIs
Get the Basic UDI-DI and the UDIs from the ‘Issuing Entities’ designated by the EU Commission such as IFA GmbH, GS1 AISBL, Health Industry Business Communications Council (HIBCC), ICCBBA.
Step II – Registration of manufacturers, EU Rep and importers
- The economic operators should register themselves in the “Actor Registration Module”, where the information of the economic operator(s) and the information relating to device needs to be entered.
- After verification of the information entered, the Competent Authority would receive a ‘Single Registration Number’ (SRN) from the electronic system which will be issued to the economic operators. The manufacturer should use this SRN for applying to the Notified Body for the conformity assessment.
Step III – Registration of Devices
- In the “UDI/Device Registration Module”, add the basic UDI- DI which is already received from the issuing entity followed by other information related to the device and the manufacturer.
- Core data elements such as quantity per package information, name and address of the manufacturer, SRN, member state information etc.
For low-risk MDs and IVDs – followed by the registration process, the EU Declaration of Conformity needs to be prepared as per the respective regulations for market launch whereas for the higher risk class devices, the Notified Body involvement is required for the conformity assessments.
Upon the audit approval for CE marking, the manufacturer should prepare the EU Declaration of Conformity for the market launch.