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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