6th MDR Eudamed
Clinical Investigation
Performance Study
WG meeting
Implementation plan update
19/09/2019
DG GROW
Content
1. Meetings
2. Project deliverables
3. Features Priorities / Status of Templates
4. State of play FS level
5. Implementation plan update
Meetings
•
19/09/2019 – Clinical Investigations WG
• 03/10/2019 – Data Exchange
• 24/10/2019 – 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
• Playground
Feature priority
Features
EUDAMED Priority
Serious Adverse Events
3rd Release (5/2021)
Application / notification Management
4th Release (5/2022)
End Report
4th Release (5/2022)
Coordinated Assessment Procedure
4th Release (5/2022)
State of play 1/7
FS-CIPS-001: Manage application/notification for CI/PS
•
Analysis and requirements to be finalised by June 2020
FS-CIPS-002: Withdraw application or notification for
CI/PS or PMCF/PMPF
•
Analysis and requirements to be finalised by November 2020
FS-CIPS-003 : Manage validation of application for CI/PS
and setting of validation date
•
Analysis and requirements to be finalised by June 2020
State of play 2/7
FS-CIPS-004: Manage authorisation of CI/PS and setting of
time limit for authorisation
•
Analysis and requirements finalised by June 2020
FS-CIPS-015: Manage list of Ethics Committees
• Analysis requirements to be finalised by January 2021
FS-CIPS-005: Enter and communicate the start of the CI/PS
or re-start after a suspension or temporary halt or start
with substantial modification
•
Analysis requirements to be finalised by January 2021
FS-CIPS-006: Manage substantial modifications to CI/PS
after authorisation or PMCF/PMPF
• Analysis requirements to be finalised by January 2021
State of play 3/7
FS-CIPS-007: Manage authorisation for substantial
modifications to CI/PS or PMCF/PMPF
• Analysis and requirements finalised by January 2021
FS-CIPS-008: Manage recording and reporting of adverse
events that occur during CI/PS
•
Analysis and requirements finalised by June 2020
FS-CIPS-009: Manage information at the end of a CI/PS or
PMCF/PMPF or in the event of a temporary halt or early
termination
• Analysis and requirements finalised by January 2021
State of play 4/7
FS-CIPS-010: Manage coordinated assessment procedure
for CI/PS
• Analysis and requirements finalised by January 2021
FS-CIPS-011: Manage exchange of information and
communication to all MS and the Commission on decisions
and the grounds therefore related to CI/PS
•
Analysis and requirements finalised by January 2021
(depending on FS-CIPS-003, FS-CIPS-004, FS-CIPS-007)
FS-CIPS-012: Search and view information on CIPS (only
for SAE)
•
SAE Analysis and requirements finalised by June 2020
• Remaining Analysis and requirements finalised by January 2021
State of play 5/7
FS-CIPS-013: Machine to machine (M2M) CI/PS
information
upload
•
SAE Analysis and requirements finalised by June 2020
• Remaining Analysis and requirements finalised by January
2021
FS-CIPS-014: Machine to machine (M2M) CI/PS
information
download
•
SAE Analysis and requirements finalised by June 2020
• Remaining Analysis and requirements finalised by January
2021
State of play 6/7
FS for public site - specifications will follow after the specifications
for the restricted site (to follow in parallel)
•
FS-PUB-CIPS-001 : Search and view CI/PS
(application/notification) information and related updates for
related information made publicly available
•
FS-PUB-CIPS-002 : Search and view CI/PS reports and
summaries made publicly available
•
FS-PUB-CIPS-003 : Search and view reported adverse events
and device deficiencies and related updates for related information
made publicly available (tbd)
•
FS-PUB-CIPS-004 : Protect subjects data
Playground
•
The Eudamed First Playground on CIPS (with SAE) will be available
around Q1 2021 (for Third Release).
Implementation Plan 1/2
Implementation Plan 2/2
Q & A
Thank-you for your
collaboration !