Medical Devices - EUDAMED

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:

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

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Fonte: EC

Collegati

	Descrizione	Livello	Dimensione	Downloads
	xml samples.zip	Abbonati Marcatura CE	56 kB	8
	Service entity model UML diagrams.zip	Abbonati Marcatura CE	931 kB	8
	Service entity model XSD.zip	Abbonati Marcatura CE	76 kB	6
	M2M data exchange services definition.pdf	Abbonati Marcatura CE	591 kB	8
	M2M data exchange services and entity models introduction.pdf	Abbonati Marcatura CE	1446 kB	12
	Data exchange guidelines.pdf	Abbonati Marcatura CE	124 kB	4
	Management of Legacy devices in EUDAMED.pdf	Abbonati Marcatura CE	1137 kB	6
	UDI device data dictionary.xlsx	Abbonati Marcatura CE	147 kB	6
	IVDR UDI and device data sets.pdf	Abbonati Marcatura CE	220 kB	4
	MDR UDI and device data sets.pdf	Abbonati Marcatura CE	259 kB	10
	Eudamed functional specifications.pdf	Abbonati Marcatura CE	2494 kB	9