2nd MDR Eudamed
CI/PS ad hoc WG
Meeting
Planning - Roadmap
19/04/2018
Slide 2
Meetings
Planned Meetings:
• 19/04/18 – 2nd CI/PS WG
• 26/04/18 – 2nd Vigilance WG
• 23/05/18 – 3rd Data Exchange WG
• 23/08/18 – 8th Actor Registration WG
• 13/09/18 – 5th NB & Certificates WG
• 27/09/18 – 5th UDI & Device WG
• 04/10/18 – 3rd Vigilance WG
• 18/10/18 – 3rd CI/PS WG
• 25/10/18 – 2nd Market Surveillance WG
• 21/11/18 – 4th Data Exchange WG
• 13/12/18 – Steering Committee
Slide 3
Implementation plan
Objectives
• Ensure Eudamed achieves full functionality (all the
must-haves) on time
• Ensure Eudamed meets the functional specifications
• Prioritisation
• Communicate timing
• Progress tracking
Slide 4
Implementation plan
Project milestones
• Eudamed Go Live before 26/03/2020 (to comply with
article 34)
• Eudamed functionally complete before Audit start –
09/2019
• Finalise functional specifications, process descriptions,
data models and business rules by 10/2018 – to allow
stakeholders to prepare their own systems (e.g. for
data exchange)
• Plan for the implementation of functional
specifications before 26 May 2018
Slide 5
Implementation plan
Project deliverables
• Eudamed information system
• Restricted site
• Public site
• Data exchange solutions
• User guide
• Technical documentation
• Training material
• Technical support
Slide 6
Implementation plan
Working documents
• Functional Specifications document contains
• Legal requirements
• Functional specifications
• Non-functional specifications
• Wireframes / Mock-ups
• Business rules
• Data models
• Process overviews
• Implementation plan with scope for 1st release
Slide 7
Implementation plan
For CI/PS:
• Functional Specifications document
• Comments from WG Members and if necessary new FS by
03/05/2018
• 2 weeks for feedback on the following draft documents
provided by COM:
•
CI/PS Process overview: first draft provided today
•
Data models:
•
First draft of logical data model for those parts for which we
have received input (application template, SEA…) : from end of
June 2018 (input needed from task force)
•
Business rules: together with data model
•
Wireframes / Mock-ups from July
• Have review iterations on these documents with the aim to
finalise in October 2018 (for CI/PS)
Slide 8
Implementation plan
For CI/PS:
• Implementation order:
1. Submit application for CI/PS and notification for PMCF/PMPF
2. Validation of application for CI/PS
3. Assessment for Authorisation of CI/PS
4. Reporting serious adverse events, device deficiencies, new
findings (CI/PS started
after date of application of MDR/IVDR)
5. Reporting serious adverse events, device deficiencies, new
findings (CI/PS started
under MDD/AIMDD / IVDD)
6. Corrective measures and information exchange between MS
7. Actions taken by the sponsor during conduct of CI/PS
8. Submission of report and summary of outcome from CI/PS
9. Coordinated assessment of single application for CI/PS to be
conducted at multiple MSs
Slide 9
Acceptance process
• Based on functional specifications
• Regular testing by WG members or delegates
when functionality has been implemented
1. Testing separate modules
2. Testing integration between modules
• On-line, test scenarios provided
• Feedback will be done through wiki
• Feedback will be analysed and used to improve
the system, in line with functional specifications
• Audit before Go-Live
Slide 10
Risks
Slide 11
Main Risks
•
Schedule imposed by the Medical Device
Regulation for the delivery of Eudamed is
not met
•
Delays because Stakeholders/MS might
take time or not reach a consensus on the
rules/specifications to be implemented
•
Eudamed too complex or inappropriate to
be useful, workable, performant and/or
user friendly
Slide 12
Main Risks
•
Disclosure of non-public data: An incorrect
implementation might result in the
disclosure of confidential data or personal
data to non-authorised persons
Slide 13
Questions?
Document Outline