The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators
Produced in partnership with Alison Dennis of Taylor Wessing LLP

The following Life Sciences practice note produced in partnership with Alison Dennis of Taylor Wessing LLP provides comprehensive and up to date legal information covering:

  • The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators
  • EUDAMED and UDI system
  • Economic operators
  • Misleading claims
  • Manufacturers
  • Manufacturers’ general obligations
  • Manufacturers’ obligations—documentation
  • Manufacturers’ obligations—summary of safety and clinical performance
  • Manufacturers’ obligations—the UDI system and data requirements
  • Manufacturers’ obligations—post-market surveillance
  • More...

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators

This Practice Note considers the European database on medical devices (EUDAMED) and the obligations of economic operators, such as manufacturers, distributors and importers of medical devices, under Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR).

For information on:

  1. key provisions of the MDR and IVDR, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

  2. scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies

  3. clinical evaluation and investigation of devices, see Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU

  4. post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU

EUDAMED and UDI system

The European Commission is tasked with expanding Eudamed2, the database under the MD Directives regime, to include information on all devices and of their manufacturers and importers and authorised representatives. The original intention was for EUDAMED to be available for use, even if not fully functional, from the date of full applicability of the MDR. However, this has been delayed until 26 May 2022, the date of full applicability of

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