Esta es la versiĆ³n HTML de un fichero adjunto a una solicitud de acceso a la informaciĆ³n 'Eudamed'.


Ref. Ares(2019)4858735 - 25/07/2019
Eudamed Roadmap 
15th July 2019 
 
Introduction 
This document presents the Eudamed High Level Roadmap as agreed between R3 and D4, with the 
main IT modules, milestones and the assumptions for a successful execution of the project.  
OUT OF SCOPE
The High Level Roadmap is based on the current knowledge of complexity of the requirements of the 
last modules to be released, namely, Vigilance, Market Surveillance, and Clinical Investigations. 
 
 
 
 
 
 
 


 
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OUT OF SCOPE
 
 


Resources 
x  Both Units recognize that delivering the agreed Roadmap will require additional resources in 
R3 from mid-2020, in particular for the delivery of releases 3 and 4. This planning brings the 
final delivery date to May 2022, 6 months earlier than the planning proposed to the MDCG 
(Medical Device Coordination Group) recently
 
OUT OF SCOPE
 
 
OUT OF SCOPE
 
 
OUT OF SCOPE
 
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