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
• 21
29/11/18 – 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