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EU Representative

Leading EU Representative for Medical Device providing EU Registration Service for Non European Medical Device Manufactures

EUDAMED Registration

EUDAMED Registration

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 Actor registration module (first module) will be available first and its deployment is expected by December 2020, the second and the third modules are expected to be made available by May 2021.

EUDAMED Implementation Enforced Now!

EUDAMED (European Database on Medical Devices) registration is now mandatory under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).  However, the full implementation of all modules of EUDAMED is delayed.

 

  1. The “Actor Registration” module is fully operational and mandatory. All manufacturers, authorized representatives, importers, and system/procedure pack producers need to register in EUDAMED to obtain a Single Registration Number (SRN).
  2. Other modules, such as UDI/Device Registration, will become mandatory after the full implementation of the database, which is expected by 2026.

 

While a few modules are already required, complete compliance with EUDAMED is expected once all modules are fully functional.

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Steps for EUDAMED Registration

Soon after the technical documentation has been compiled, and has appointed the EU Representative, 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), and 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 the 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 EUDAMED 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.

We are a European Authorized Representative for Medical Devices and IVD,s. We also provide EUDAMED Registration for all our Foreign manufacturers. Contact us for more details and pricing.
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Frequently Asked Questions

What are the documents required for EUDAMED registration?

The following are the documents required for EUDAMED registration and Device Listing.

  1. EAR Agreement (For manufactures Only)
  2. EAR Mandate  (For manufacturers Only)
  3. Declaration of Conformity
  4. Manufactures Declaration
  5. PRRC details

EUDAMED registration Timeline?

The average timeline is 2 to 3 weeks.

Does UDI updating a must now?

Once the UDI/Device Registration module in EUDAMED becomes fully operational, manufacturers will need to update their device information in the system, including the UDI. Until then, UDI updates may be handled through national regulatory systems or databases, depending on the Member State’s provisions.