Importance of EUDAMED in medical device registration in European Union (EU)

Introduction:

The European Commission adopted new regulations in 2017 and they are Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). Main goal of MDR and IVDR is to improve the transparency and data coordination of medical devices distributed and marketed in EU. To accomplish this, European Database for Medical Devices (EUDAMED) was established.

EUDAMED is considered as an IT system to monitor the safety and performance of medical devices regulated under both MDR and IVDR. It provides a real time scenario of medical devices made available in the EU. It will integrate different electronic systems in one place and process the available information related to medical devices and related companies (e.g., manufacturers).

The Commission Implementing Regulation (EU) 2021/2078 is responsible for setting up and maintenance of EUDAMED. The main purpose of EUDAMED is to improve transparency and coordination of information regarding medical devices available on the EU market. EUDAMED aims to increase overall transparency by boosting the quality, safety, and reliability of medical devices by introducing stricter controls on high-risk devices, clinical evaluations, investigations, and the Notified Bodies that approve the certification of medical devices. EUDAMED also helps to enhance vigilance and market surveillance of medical devices even after introducing them in to the market.

EUDAMED consists of six interconnected modules: Actors registration, UDI/Devices registration, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance.

How does EUDAMED work?

If you are a manufacturer, authorized representative or importer of a medical device. In order to gain access to EUDAMED, you must first apply for a Single Registration Number (SRN) in the EUDAMED actor module. Application will be checked in the EU Member State where you are established. The competent authority will approve your application once the data entered is correct and complete, and EUDAMED will subsequently grant you a SRN.

After the successful generation of SRN, access is needed in order to:

-Request a conformity assessment from a notified body

-Provide mandatory product information about medical devices. This includes the unique device identifier (UDI), the notified body that has assessed the device and the issued CE-certificate

-Provide information on clinical trials and performance studies carried out

-Record vigilance data, such as information on incidents and corrective actions

Who else gets access to EUDAMED?

Besides manufacturers, authorised representatives, importers and notified bodies, regulatory bodies will also have access to EUDAMED. In addition, healthcare institutions, healthcare providers and citizens also have access to the publicly available components of EUDAMED. They are free to check the information about medical devices, side effects and incidents, but they cannot register themselves.