What Is EUDAMED Registration?

EUDAMED is the European Databank on Medical Devices, a centralized database that will contain information on medical devices and the entities involved in their supply chain in the EU. In EUDAMED, an Authorised Representative (AR) is a person or entity appointed by a manufacturer based outside of the EU to act on their behalf in relation to specific tasks related to conformity assessment procedures and related duties. The AR is responsible for ensuring that the manufacturer fulfills its obligations under EU medical device regulations.

• The EU MDR (2017/745) and and EU IVDR (2017/746) state that, regardless of the device class, to place a device into the EU market, a manufacturer established outside the EU, is required to have an EU Authorized Representative. The representative must be located within the European Union and is designated with a mandate. Brilitas, a member of the European Commission and headquartered in Estonia, will act as your authorized representative to register your medical device at EUDAMED with the optimal fee and many incentives attached. 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.

• Manufacturers outside the EU/EEA will benefit greatly once the product is licensed by the EUDAMED. When your medical devices are licensed by the EUDAMED, the likelihood of it being accepted and approved by the Competent authorities of all countries worldwide is high, with fast procedures, easy distribution and marketing globally.
  

The EUDAMED registration is valid for an indefinite period of time, as long as the information provided by the registrant remains accurate and up-to-date. The registrant is responsible for updating their information in the EUDAMED database in a timely manner and notifying the competent authorities of any changes to their registration information. However, it should be noted that the European Commission may conduct periodic reviews of the information provided in EUDAMED to ensure its accuracy and completeness.

The detailed process is regulated by the European Commission through a general diagram provided here. 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. The appointment of a Notifier Body will be made by Brilitas on your behalf.

Brilitas offers EU Authorized Representative service for non-EU medical device manufacturers, who want to access the European market. Brilitas will guide you through the process of EU Authorized Representative designation. Once the service is up and running, MDBS will carry out all the EU Authorized Representative duties for you as required in EU MDR (2017/745) and EU IVDR (2017/746).

Brilitas shall:

• Become your point of contact at European Commission

• Provide you with the necessary documents and records
  

• Give you useful tips to get your application quickly
  

• Apply for EUDAMED registration on your behalf