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.
ut
ntinue througho
co
ill
w
which
ease.
and
6
1
0
rticular rel
ted in 2
tar
of a pa
y,
was s
onalit
which
functi
of
s
m
quirements
ter
re
ess
sin
ped, in
lo
ve
of bu
ysis
anal
modules de
on the
main
ed
e the
orm
perf
rk
k will b
o
w
e
an asteris
ect th
refl
with
t
o
es n
o
admap
o
marked
map d
ect.
evel R
modules
High L
The
This road
the proj
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
(OHFWURQLFDOO\ VLJQHG RQ 87& LQ DFFRUGDQFH ZLWK DUWLFOH 9DOLGLW\ RI HOHFWURQLF GRFXPHQWV RI &RPPLVVLRQ 'HFLVLRQ