Last year, the European Commission has announced that EUDAMED 3 as one central aspect for the implementation of important medical devices regulation (MDR) and IVD regulation (IVDR) mechanisms, will not be fully available before May 2022. In March 2020, the Commission then confirmed that the six modules of EUDAMED 3 will be made available sequentially.
In August 2020, the Medical Device Coordination Group (MDCG) has issued guidance MDCG 2020-15. It says that the economic operator registration module will be available as of December 1, 2020. This module will serve to obtain the Single Registration Number (SRN), which is a prerequisite to get access to other EUDAMED core functions.
Source: MDCG guidance
In order to receive more informations on Guidance Documents you might chose from the following options
- Browse our website by keyword guidance documents.
- Read our paragraph “Major aspects of the MDR”.
- Read our article “Most important changes on MDR“.
- Read our article “Early access to Single Registration Numbers (SRN)“.
- Read our article “Device Registration and Legacy Devices“.
- Read our article “Updated timetable for Eudamed“.