This is an HTML version of an attachment to the Freedom of Information request 'Eudamed'.

5th MDR Eudamed 
UDI & Devices ad hoc 
WG Meeting
Implementation plan update for UDI 
& Devices
27/09/2018


Slide 2
Meetings
Planned Meetings:
• 27/09/18 – 5th UDI & Device WG
• 04/10/18 – 3rd Vigilance CI/PS WG
• 18/10/18 – 3rd CI/PS Vigilance WG
• 25/10/18 – 2nd Market Surveillance WG
• 2129/11/18 – 4th Data Exchange WG
• 13/12/18 – Steering Committee
• 29/01/19 – 9th Actor Registration WG
• 21/02/19 – 6th NB & Certificates WG
• 14/03/19 – 6th UDI & Device WG


Slide 3
Implementation plan
Working documents
• Functional Specifications document contains
• Legal requirements
• Functional specifications
• Non-functional specifications
• Process overviews / use cases
• Wireframes / Mock-ups
• Business rules
• Data models
• Implementation plan 


Slide 4
CRF - State of Play
• Functional Specifications document 
• a new version following last MDCG meeting, discussions and 
feedback received from Member States & stakeholders has 
been sent to MDCG and WGs
• Implementation plan
• Update will be sent after inclusion of the new version of the 
functional specifications


Slide 5
CRF - State of Play
• Documents for review for UDI & Devices (UDID)
• Business Processes – were sent for review
• Use Cases – will be presented later today
• Business Rules (BR) - BR were sent, list of BR is being 
updated as the detailed functional analysis advances
• Entity Model – Entity model for Basic UDI DI Data, UDI DI 
Data and Device Data were sent
• Security Matrix – will be presented later today
• Wireframes / Mock-ups  for UDID - Registration of Devices, 
Updates on Devices, Search and View Device Information –
will be presented later today
• Expect to finalise versions by beginning December in 
collaboration with WG


Slide 6
State of Play
• Delay of 3-5 months for UDID module implementation
1. UDI registration for MF and non-EU MF (with prevention of 
duplicates) with exception of systems and procedure packs
FS-UDID-002.05 
UC_UDID_01. Registration of the Basic 
FS-UDID-002.08
UDI and UDI DI
FS-UDID-002.04
90% implemented - (todo: finalization 
ongoing tasks, Basic UDI-DI & UDI-DI 
Management, some changes)
FS-UDID-002.09
UC_UDID_02. Registration of UDI DI 
for existing BASIC UDI
Mockups ready for review
To be implemented next


Slide 7
State of Play
2. Device registration for MF and non-EU MF
FS-UDID-003.01
UC_UDID_03 : Registration of Device 
Data for an existing UDI DI
mockups are ready for review
50% implemented 
FS-UDID-002.05  UC_UDID_04: Registration of Container 
FS-UDID-002.08
Package Information for an existing UDI 
DI 
based on UC_UDID_01
mock ups to be updated, to be implemented


Slide 8
State of Play
3. Search and view UDI-DI and Device data 
FS-UDID-006.01
UC_UDID_15: Search and View Device 
FS-UDID-006.02
Data
mockups are ready for review
To be implemented
Tests for functionalities in points 1, 2 , 3 : 
planned for end of 01/2019


Slide 9
State of Play
4. UDI update and Device update - mock ups to be updated, to 
be implemented
FS-UDID-002.06
UC_UDID_06: Update Basic UDI DI/Device 
FS-UDID-002.04
information
FS-UDID-003.02
UC_UDID_07: Update UDI DI/ Device 
information
5. Systems and procedure packs - some mockups to be done, 
similar to UC_UDID_01, some fields to change
FS-UDID-002.01
UC_UDID_05: Registration of System or 
FS-UDID-002.04
Procedure Pack
FS-UDID-002.02
UC_UDID_08: Update System or Procedure 
FS-UDID-002.04
Pack data


Slide 10
State of Play
6. Enable NB to upload the SS(C)P and enter related meta-data 
to device data already provided by a manufacturer - mockups 
to be done, to be implemented
FS-UDID-009.01 UC_UDID_13: Upload SS (C) P and enter 
specific metadata
7. Enable NB to manage the information on certificate ID in device 
data (confirm, reject or enter/update) – Dependant on CRF 
FS-UDID-005.01 UC_UDID_10: Link Device with Certificates
mockups to be updated (based on changes in CRF) 
UC_UDID_11: Confirm Certificate Link 
between Device and Certificate
mockups to be done, to be implemented
UC_UDID_12: Manage  the Link between 
Device and Certificate of type QMS or QA
mockups to be done, to be implemented


Slide 11
State of Play
8. Register specific device types requiring specific rules
Part of normal registration
9. Enable an AR to indicate its disagreement with information 
related to a Basic UDI-DI and related UDI-DI and device 
information 
FS-UDID-004.01
UC_UDID_09: Authorized 
Representative  indicate disagreement
10.Device Nomenclature data management (depending on 
decision for Device Nomenclature)
11.Search and view Device Nomenclature data
FS-UDID-007 UC_UDID_16: 
Search 
Device 
Nomenclature and View Nomenclature 
Details
device nomenclature to be decided, 
maintenance workflow to be decided


Slide 12
State of Play
For 2nd release:
FS-UDID-010.01: Enable manufacturers to link one of its Basic 
UDI-DI to another one and to give a reason
~UC_UDID_14 Link a Basic UDI to another Basic UDI


Slide 13
State of Play
• In parallel with implementation of other FS –
• FS-UDID-008 : (M2M) Upload and Download of Basic UDI-
DI, UDI-DI and device data
• FS-EUD-004 : Notification/Information email system 
• Done: engine to prepare and send emails
• To do: management of subscriptions (will be managed in 
the Actor module for all modules) and content of emails 
for the UDID module


Slide 14
State of Play
• FS for public site - specifications will follow after the 
specifications for the restricted site
• FS-PUB-UDID-001.01: List all (Basic) UDI-DIs and devices 
whose UDI-DI and Device data match a set of search criteria 
provided by the user
• FS-PUB-UDID-001.02: Display registered (Basic) UDI-DI 
data and Device data of a Device associated to a Basic UDI-
DI or uniquely identified by a combination of other criteria
• FS-PUB-UDID-001.03: Allow to search and view medical 
devices nomenclature codes and their related information 
(name, description …)
• FS-PUB-UDID-002.01: Enable downloading in a file the 
registered (Basic) UDI-DI data and Device data of Devices 
associated to a search result (limited in size content)


Slide 15
testing
• 1st User testing for UDID module was planned for 27 
September – rescheduled to end 01/2019
• Acceptance testing for UDID module was planned from 
05/03/19 – rescheduled to 06/2019


Slide 16
Questions?

Document Outline