6th MDR Eudamed
UDI & Devices WG
Meeting
Implementation plan update
14/03/2019
DG GROW
Content
1. Meetings
2. Project deliverables
3. Working documents
4. State of play FS level
5. Implementation plan update
Meetings
• 14/03/2019 - UDI & Device WG
• 21/03/2019 - Data Exchange WG
• 28/03/2019 – Vigilance WG
• 16/05/2019 – Clinical Investigations WG
• 23/05/2019 – Market Surveillance WG
• 20/06/2019 – NB & Certificates WG
Project deliverables
• Eudamed information system
• Restricted site
• Public site
• Data Exchange solutions
• User guide
• Technical documentation (for Data Exchange)
• Training material
• Application Support
• Demos / Playground
Working Documents
Document
Date
1
Functional Specifications v4.1
7/3/19
2
Business Process
v2.0
5/3/19
3
Entity Model
v2.0
5/3/19
4
Security Matrix
v2.0
7/3/19
Comments of
5
Business Rules
v2.0
at WG
WG members
6
Data Dictionary
v2.0
5/3/19
till
29-03-2019
7
Use Case Register
v2.0
7/3/19
8
Mock-ups
v2.0
at WG
9
Site Maps (restricted, public)
7/3/19
10 Search criteria
7/3/19
11 Implementation Plan
v2.0
at WG
(this ppt)
State of Play 1/8
FS-UDID-002.05, FS-UDID-002.08, FS-UDID-002.09
UDI registration for MF and non-EU MF (with prevention
of duplicates)
•
Analysis completed;
•
Implementation of Registration process of Basic UDI-DI and UDI-DI
is completed,
•
remaining following Use cases: Registration of UDI-DI for existing
Basic UDI and Registration of Package Level UDI for existing UDI;
FS-UDID-003.01 Device registration for MF and non-EU
MF
•
Analysis completed
•
Implementation in progress - working now on UC Register Device
Data for existing UDI-DI
State of Play 2/8
FS-UDID-006.01, FS-UDID-006.02
Search, view and download UDI-DI and Device data incl.
SS(C)P
• Analysis completed
• Implementation ongoing
FS-UDID-002.06 Basic UDI, UDI-DI update
• Analysis completed
• Implementation ongoing
FS-UDID-003.02 Device data update (except SS(C)P)
• Analysis completed
• Implementation ongoing
State of Play 3/8
FS-UDID-002.01
Registration of Systems and Procedure packs
Analysis completed;
Implementation: Q3 2019;
FS-UDID-002.02
Update System and Procedure packs
Analysis completed;
Implementation: Q3 2019;
State of Play 4/8
FS-UDID-005.01
Enable NB to confirm Device data with related
Certificate data
• Analysis started
• Dependency on the implementation on the Certificate
Module (Q3 2019)
FS-UDID-009
Enable NB to upload the SS(C)P and enter related
meta-data to device data already provided by a
manufacturer
• Analysis started
State of Play 5/8
FS-UDID-001.01
Device Nomenclature data management
FS-UDID-007
Search and view Device Nomenclature data
• Device Nomenclature has been established March 2019
(CND Nomenclature – mapped with GMDN)
• Analysis started
State of Play 6/8
FS-UDID-004 Priority
– Medium
Enable an AR to indicate its disagreement with
information related to a Basic UDI-DI / UDI / Device
information referencing this AR
• To be analysed & implemented in a future release
FS-UDID-010 Priority
– Low
Enable MF to link one of its Basic UDI-DI to another one
and give a reason
• To be analysed & implemented in a future release
State of Play – M2M 7/8
FS-UDID-008 Upload and Download of Basic UDI, UDI-DI
and device data
•
FS-UDID-008.01 : Enable Upload for EU, Non-EU Manufacturers
Analysis on-going
Testing to be planned (not earlier than June 2019)
•
FS-UDID-008.02 : Enable Upload for System/Procedure pack
Producers
Analysis on-going
Testing to be planned (not earlier than June 2019)
•
FS-UDID-008.03 : Enable Downloading (not for Sponsor)
Analysis on-going
Testing to be planned (not earlier than June 2019)
State of Play – Public Site 8/8
FS-PUB-UDID-001 : Search and view UDI-DI and
Device data (including SS(C)P)
Analysis Started
FS-PUB-UDID-002 : Download UDI-DI and Device
data (including SS(C)P)
Analysis to start Q2 2019
Playground and demos
•
The Eudamed playground on UDI will be available in Q2. Exact date
will be communicated
•
The same functional mailbox for questions
and comments is valid (GROW EUDAMED
SUPPORT)
•
Videos/demos will also be available from
CIRCABC on the
DEMO library
Implementation Plan update
2019
2020
MAR
APR
MAY
JUN JUL
AUG
SEP
OCT
NOV
DEC
JAN
FEB
MAR
Stable Req
Stable Req
100% of
80% of Use
Use Cases
Cases
UDI : Analysis
1st REL
UDI: Development
AUDIT: UDI
Demo
Playground
Final
Report
UDI: Fixes, Updates