Meeting minutes - 08.Oct.2015 (1 reply)
|DIA EDM Reference Model - Devices
|17:00 (CET) - Europe Time (Rome, GMT+01:00)
|Merz Pharma (DE)
|Discussions and Action Items
|Discussion & Required Action
|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
|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
|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
|Proposed artifact namesshould be unique regardless of its position within the model in order to avoid confusion. Check for duplicates should be performed.
|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.
|Metadata mapping should be checked
|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
|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
|On hold (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.
|How to improve the visibility of the team and the initiative.
|Spread the info around – list of potential members / contributors
|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
|Webex – technical issue with voice quality
|dial-in option should be investigated
|The VOIP quality seems to be OK.
|Structure mapping between RPS nIVD and STED nIVD (TAB07)
|Review the current mapping between RPS and STED (TAB 07)
|ConsiderIDMRF Consultations and Documents
|Especially - Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions (http://imdrf.org/consultations/cons-rps-atg-imdrf-toc-150409.asp )
|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.
|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)
|Once we have the definition of terms, it will be used to create unique coding
|On hold (04b)
|Artefacts meta data
|Start to identify required meta data fields: -Mandatory (M) -Optional (O)
|On hold (04b)
|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 – https://edmrefmodel.com/device-reference-model-team/
|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