As part of the new MDR, the European Commission developed a secure database called EUDAMED to improve transparency and coordination of information regarding medical devices on the EU market.
The Actor Registration module went live on December 1, 2020. Economic operators are encouraged to register with the system and obtain a single registration number (SRN) to meet the requirements of the regulation. The operation of all six modules is necessary for full MDR implementation and is scheduled for May 2022.
Section 2: Key Changes Under New MDR
Economic Operator Roles and Responsibilities
Clinical Evaluations and Post-Market Clinical Follow-up (PMCF)
Post-Market Surveillance (PMS)
European Database for Medical Devices (EUDAMED)
Serious Incident and Corrective Action Reporting
Section 3: Quality Management System (QMS) Requirements
Section 4: Steps for a Successful EU MDR Implementation
Section 5: MDR Implementation Checklist
Section 7: Appendix - Frequently Asked Questions & MDR Quick Guide