ID 13951 | 09.07.2021 / Documentazione allegata
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives (Eudamed2).
EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market.
The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and will be interoperable.
EUDAMED is structured around 6 interconnected modules and a public website:
It is the first of six EUDAMED modules. UDI/Devices registration Notified Bodies and Certificates Clinical Investigations and performance studies Vigilance and post-market surveillance Market Surveillance Actors registration
On 1 December 2020 the European Commission has made available the Actor registration module.
- EUDAMED restricted
- EUDAMED public
The Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional according to the Medical Device Regulation and additional national requirements on registrations can therefore not be excluded.
What is the state of play of the implementation of EUDAMED?
The development and implementation of EUDAMED is a high priority for the Commission
The module on Actor registration is available since December 2020
The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available in September 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. Afterwards, the remaining modules as well as the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.
Functional specifications
The Eudamed functional specifications have been public since February 2019. These functional specifications might be subject to possible changes as some issues are still under discussion.
MDR/IVDR UDI and device
Overview of the MDR UDI and device data sets and IVDR UDI and device data set to provide for their registration in EUDAMED.
EUDAMED UDI device data dictionary. This document clarifies the data that you should provide to EUDAMED for the UDI device registration module.
Management of Legacy devices in EUDAMED - Updated version (1.2) - February 2021
Data exchange
Data exchange guidelines
Machine-to-machine (M2M) data exchange documentation for economic operators
- M2M data exchange services and entity models introduction
- M2M data exchange services definition
- Service entity model XSD
- Service entity model UML diagrams
- xml samples
...
Fonte: EC
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