2nd MDR Eudamed
Market Surveillance
ad hoc WG Meeting
Implementation plan update for
Market Surveillance Module –
Planning - Roadmap
25/10/2018
Meetings
Slide 2
Planned Meetings:
•
25/10/18 – 2nd Market Surveillance WG
•
29/11/18 – 4th Data Exchange WG
•
13/12/18 – Steering Committee
•
29/01/19 – 9th Actor Registration WG
•
07/02/19 – 4th Clinical Investigations WG
•
14/02/19 – 4th Vigilance WG
•
21/02/19 – 6th NB & Certificates WG
•
14/03/19 – 6th UDI & Device WG
•
21/03/19 – 5th Data Exchange WG
•
28/03/19 – 3rd Market Surveillance WG
Working Documents
Slide 3
• Functional Specifications document contains
• Legal requirements
• Functional specifications
• Non-functional specifications
• Process overviews / use cases
• Wireframes / Mock-ups
• Business rules
• Data models
• Implementation plan
Analysis Overview
Slide 4
Domain
Stakeholders
Status
Description
Secure
Legal Requirements
EC, WG, MDCG
Version 2.0
High Level Specification
EC, WG, MDCG
Version 2.0
Detailed Requirement
EC, WG
Ongoing
gathering
Business Process
EC, WG
Ongoing
Entity Model
EC, WG
Ongoing
Business Rules
EC, WG
Ongoing
Wireframes
EC, WG
Not Started
Mock-ups
EC, WG
Not Started
Validation
EC
Not Started
Public
Legal Requirements
EC, WG, MDCG
Version 2.0
High Level Specification
EC, WG, MDCG
Version 2.0
Detailed Requirement
EC, WG
Ongoing
gathering
Business Process
EC, WG
Not required, read only for public for one use case
Business Rules
EC, WG
Ongoing
Wireframes
EC, WG
Not Started
Mock-ups
EC, WG
Not Started
Validation
EC
Not Started
Machine-to-Machine
Legal Requirements
EC, WG, MDCG
Version 2.0
High Level Specification
EC, WG, MDCG
Version 2.0
Services
EC, WG
Not Started
XML Samples
EC, WG
Not Started
Business Rules
EC, WG
Not Started
Validation
EC
Not Started
MSU- State of Play
Slide 5
• Functional Specifications document V2.0
•
LR-MSU-012 : Non-compliant measures definition
modification
•
LR-MSU-021 : Non-compliant measures definition
modification
•
LR-MSU-026 : Notified body access to MSU
•
LR-MSU-027 : Notifications to be sent to notified bodies
•
LR-NFS-002 : Reformulate description
• Implementation plan
• Update will be sent after inclusion of the new version
of the functional specifications
MSU - State of Play
Slide 6
Legend for the following slides:
Priority in High Functional Specs – Status of analysis – Analysis Finalized
GROW R3
Slide 7
MSU - State of Play
MSU Restricted FS – sorted by Priority
1. FS-MSU-002 : Manage the final inspection reports of the MS
High – Collect Requirements – Define Template – 11/18
2. FS-MSU-008 : Search and view information on market
surveillance
High – Collect Requirements - 3/19 (Functionality added for
each FS)
3. FS-MSU-005 : Manage notification and exchange information
on devices presenting an unacceptable risk to health and
safety
High – Collect Requirements – 1/19
GROW R3
Slide 8
MSU - State of Play
MSU Restricted FS – sorted by Priority
4. FS-MSU-006 : Manage information on measures taken for a
non-compliant device not presenting an unacceptable risk to
health or safety or other aspects of the protection of public
health
High – Collect Requirements – 1/19
5. FS-MSU-007 : Manage notification on preventive health
protection measures
High – Collect Requirements – 1/19
GROW R3
Slide 9
MSU - State of Play
MSU Restricted FS – Further release
6. FS-MSU-001 : Manage the annual summaries of the results of
the surveillance activities of the MS
Medium– Collect Requirements – Define Template – Further
Release
7. FS-MSU-003 : Manage the summaries of the results of the
reviews and assessment of the market surveillance activities of
the MS
Medium– Collect Requirements – Define Template – Further
release
GROW R3
Slide 10
MSU - State of Play
MSU Restricted FS – Further release
8. FS-MSU-004 : Communicate results of the review and
assessment by the MS of the functioning of its market
surveillance activities
Medium– Collect Requirements – Define Template – Further
release
9. FS-MSU-011 : Platform for cooperation and collaboration
between MS and between MS and the Commission
Medium – Collect Requirements – Further release
GROW R3
State of Play
Slide 11
MSU Machine to Machine FS – sorted by Priority
1. FS-MSU-009 : Machine to machine (M2M) market surveillance
data Download
High – Collect Requirements / Services – 2/19
2. FS-MSU-010 : Machine to machine (M2M) market surveillance
data Upload
High – Collect Requirements / Services – 3/19
State of Play
Slide 12
MSU Public FS
FS-PUB-MSU-001 : Search and view a summary of the results of
the reviews and assessments of the market surveillance activities
of a MS
Medium – Collect Requirements / Services – Further Release
Moving Forward
Slide 13
•
Establish a communication channel with COEN Eudamed TF
•
COEN to provide feedback on provided detailed analysis
•
COEN to provide meta-data for form content
•
Collaboration with COEN in defining requirements
•
Finalize all Detailed Requirements by next WG (03/19)
Slide 14
Questions?
Document Outline