Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
There are many questions and doubts concerning the European Database for Medical Devices, EUDAMED, and how to be compliant to the Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR) in the absence of the full functionality of EUDAMED.
Even if the full application of the MDR has been postponed to May 26th, 2021 due to the corona virus pandemic, EUDAMED is expected to be fully operational by May 2022, leaving a one-year gap between the two dates.
The Medical Device Coordination Group has released a new guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional juts a few days ago.
This document provides guidance on the application of certain MDR provisions during the absence of EUDAMED to enable Member States and other relevant parties to meet their obligations under the MDR effectively. It is important to remember that all MDR requirements will apply as relevant, this means the obligation of generating certain information (for example: UDI, Summary of Safety and Performance (SSCP), Periodic safety update report (PSUR)) even if they cannot jet be uploaded to EUDAMED.
The guidance provides a table displaying the articles of the MDR concerning the use of EUDAMED and the suggested alternative solutions to submit and/or exchange information.
See also our other post: Management of Legacy Devices in Eudamed
For the whole document please click link below.