EUDAMED ACTOR AND DEVICE REGISTRATION

EUDAMED (European Database on Medical Devices) is a database established for the regulation and monitoring of medical devices within the European Union. It has been developed in compliance with the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) to enhance transparency and ensure traceability of medical devices and economic operators.

The EUDAMED system includes the registration of both economic operators and medical devices.

EUDAMED Actor Registration

Actor registration in EUDAMED ensures that all economic operators involved with medical devices (manufacturers, importers, authorized representatives, and distributors) comply with EU regulations by being registered in the system.

Who Needs to Register?

• Manufacturers (both inside and outside the EU)

• Authorized Representatives (for manufacturers outside the EU)

• Importers

• System and Procedure Pack Producers
  
  

Actor Registration Process

1. Obtaining an SRN (Single Registration Number)

   • After registration, each economic operator is assigned a unique SRN, which is used in all EUDAMED records and documents.

2. Data Entry

   • Company details, address, contact information, and economic operator type must be entered into the EUDAMED system.

3. Approval by Competent Authority

   • The registration must be approved by the relevant national competent authority (e.g., TİTCK in Turkey).

EUDAMED Device Registration

EUDAMED device registration ensures that medical devices are recorded in the system, enabling transparent traceability and regulatory compliance.

Which Devices Must Be Registered?

• Medical devices (including low, medium, and high-risk classes)

• Active implantable medical devices

• In vitro diagnostic (IVD) devices
  
  

Device Registration Process

1. Generating a Unique Device Identifier (UDI)

• A Unique Device Identifier (UDI) must be assigned to each device.

• The UDI ensures proper identification and traceability of the device.
  
  

2. Uploading Technical Information and Documentation

• Information such as intended use, classification, design specifications, and instructions for use must be submitted to the system.
  
  

3. Updates and Post-Market Surveillance (PMS)

• Device information must be regularly updated.

• Post-Market Surveillance (PMS) data must be recorded after the device is placed on the market.
  
  

Key Benefits of EUDAMED

✅ Transparency: Device information is accessible to regulators, manufacturers, and the public.
✅ Traceability: Facilitates monitoring of devices throughout their lifecycle.
✅ Regulatory Compliance: Ensures adherence to EU regulations and simplifies audits.
✅ Safety: Enhances device safety by enabling early detection of potential issues.