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Meeting minutes - 08.Oct.2015 (1 reply)

9 years ago
Romuald 9 years ago
Meeting Purpose DIA EDM Reference Model - Devices
Meeting Date 08.Oct.2015
Meeting Time 17:00 (CET) - Europe Time (Rome, GMT+01:00)
Meeting Location Webex
Meeting Facilitator Romuald Braun
Meeting Attendees Company Name
Anteis (CH) Arnaud Biermann
Merz Pharma (DE) Christine Schaumburg
TEVA Rowland Lewis
Fresenius Yong Liu
Discussions and Action Items
# Topic Discussed Discussion & Required Action
(if any)
Assigned To Due Date
00 Review of minutes and open topics from previous meeting Romuald will distribute an email with the request of deleting all existing bi-weekly calls and send a new sequence of requests starting on 22.Oct.2015 All
02a.a RPS vs. US 510k mapping
Yong prepared a mapping between RPS IVD vs. US 510kand RPS nIVD vs. US 510k. -Because RPS is not yet implemented, it is based on personal view and understanding
Yong Done
We have to include additional 2 tabs into our xsl document – to have all comparison in one place à new version MAPPING_DIA EDM Reference Mode_10 Metod Done
02c Proposed artifact namesshould be unique regardless of its position within the model in order to avoid confusion. Check for duplicates should be performed. All Future
02d Proposed artifact names should be checked in the context of the authoring process. In case artifacts are in reality authored as several sub-artifacts and later compiled together, another level of sub-artifacts should be introduced to cover this scenario. All Future
03 Metadata matrix Metadata mapping should be checked All Future
04 Terminology used in Reference Model Suggestion to introduce additional column(s) for definition of terms – to standardise and to have common understanding. This topic is closely related to several other topics and for the time being we need first to define – review the terms to standardise and to have common understanding

04a Try to add additional columns and assess/discuss the complexity with the team
Example was prepared on tab Regulatory Admin where the additional column (L - Definition / Purpose) was inserted. The approach would be – make it simple, use the existing definitions where possible and not to go into regional/ country specifics.

It would be appreciated if the workload can be widespread within the team to easily cover all items

Metod On hold (04b)
04b Review the Terms Definition section of the Quality Model to see, how it can be leveraged. It seems, terms need to be defined before continuing the work with following items: -02c -02d





Romuald will take the 1st look and suggest an approach leveraging the work done in Quality.

The result of the discussion with the Quality Model team was: they did it one by one.

Romuald prepared a starting point file and agreed to send it all participants od this call.

Everyone will pick one term and provide a definition back to Romuald before next call. This should kick off the process.

Romuald Ongoing
05 How to improve the visibility of the team and the initiative. Spread the info around – list of potential members / contributors All Ongoing
05a Approach medical devices forums and associations to test their motivation to join the Ref. Model initiative: -IMDRF -ADVAMED


(See links below)

Romuald B. In progress Ongoing
06 Webex – technical issue with voice quality dial-in option should be investigated Romuald B. Done
The VOIP quality seems to be OK.
07 Structure mapping between RPS nIVD and STED nIVD (TAB07) Review the current mapping between RPS and STED (TAB 07) Romuald U. Ongoing
08 ConsiderIDMRF Consultations and Documents Especially - Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions ( ) Future
09a Excel sheets Question was raised whether it would be more convenient if the reference model sheets should be separated from the mapping sheets in order to have 2 leaner excel files. Steve’s opinion was to keep all the things in one sheet to facilitate consistency. Done
09b Model mapping Question was raised whether to use unique coding for each model (RPS codes should be used just for cross-reference and not as primary coding). When cross-checked with the Submission reference model, they don’t use specific coding and present CTD mapping on in the attributes section. On hold (04b)
09b.a Once we have the definition of terms, it will be used to create unique coding On hold (04b)
10 Artefacts meta data Start to identify required meta data fields: -Mandatory (M) -Optional (O)


On hold (04b)
10a We should use those individual tabs for future work. Who should do what? à Next time? RPS_RM_Sort by Group was break-down to individual xls sheets per Domain: -Regulatory Admin – contains proposed meta data fields (without info for M/O) -Quality – contains some meta data fields together with draft proposal for M/O

-Labeling - contains some meta data fields together with draft proposal for Cardinality

-Non-clinical - contains proposed meta data fields (without info for M/O)

-Clinical – same as Non-clinical - contains proposed meta data field


DIA EDM Reference Model – Devices: general info & References for RM:
Web site for communication and exchange –
STED – Authoring Group: Study Group 1 of the Global Harmonization Task Force
Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED), February 21, 2008
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, March 17th, 2011
RPS – Authoring Group: Regulated Product Submissions Table of Contents Working Group, 2014
Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)
In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
Medical Devices Forums and Associations
International Medical Device Regulators Forum
Advanced Medical Technology Association
MedTech Europe
9 years ago
Romuald 9 years ago

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