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Meeting Minutes_07.05.2015 (No replies)

Metod
9 years ago
Metod 9 years ago

Dear,

Please find enclosed Meeting minutes.

Regards,

Metod

Meeting Purpose DIA EDM Reference Model - Devices
Meeting Date 07.05.2015
Meeting Time 17:00 (CET) - Europe Time (Rome, GMT+01:00)
Meeting Location Webex
Meeting Facilitator Renato Rjavec in absence of Romuald Braun
Meeting Attendees Company Name
Infotehna Eric Haase
Infotehna Metod Ostanek
Infotehna Renato Rjavec
Abbvie Eric Cardwell
indepentent Steve Scribner
Fresenius Kabi Yong Liu
Valeant MD Romuald Urbanski
Nextdocs Brooke Casselberry
Valeant MD Agnieszka ?? (Wanat or Wiktorowska)
Discussions and Action Items
# Topic Discussed Discussion & Required Action
(if any)		 Assigned To Due Date
01 STED Structure vs RPS Structure Check the STED structure provided by Romuald Urbanski M. Ostanek – done
01a Compare the STED structure against RPS structure. M. Ostanek – done
01b Updated excel prepared containing several different comparisons: Sheet Naming:

  • Doc_History = Document history
  • References = list of references used
  • 01 RPS_IVD_TOC = HIERARCHY PRESENTATION of InVitro Diagnostic Medical Devices Market Authorization Table of Contents
  • 02 RPS_nIVD_TOC = HIERARCHY PRESENTATION of Non-In Vitro Diagnostic Devices Market Authorization Table of Contents
  • 03 RPS_nIVD vs RPS IVD_TOC = comparison of TOC between Non-In Vitro Diagnostic Devices and In Vitro Diagnostic Medical Devices
  • Generally the TOC up to 2nd level is almost the same with some minor differences (4/61 - see coloured rows). Chapter 3 Non-Clinical Studies has different content concerning studies - see comments.
  • 04 STED_nIVD = STED TOC - modules and content for Non-In Vitro Diagnostic Devices Market Authorization
  • 05 STED_IVD = STED TOC - modules and content for In Vitro Diagnostic Devices Market Authorization
  • 06 STED nIVD vs STED IVD = comparison of STED TOC with cross-references
  • 07 STED_nIVD vs RPS_nIVD = comparison of TOC with cross-references - STED vs RPS

Note: to be in line with the content we’ve changed the naming for previous sheets:

  • RPS_reference Model = previous sheet /STED reference model/ renamed to RPS
  • RPS_RM_Sort by Group = previous sheet was renamed /STED reference model/ renamed

M. Ostanek – done
02 Devices reference Model – updated excel was presented and the new content was discussed. Presented by R. Rjavec. Discussion about STED vs RPS structure as a baseline for the device reference model:

  • Majority of participants who expressed their opinion (Brooke, Steve, Yong, Renato) are more keen to continue with RPS, while some have concerns about its complexity compared to STED structure (Romuald U.)
  • It was explained that STED represents a subset of RPS and the reference model should be comprehensive, while actual implementation may cover only a specific subset (e.g. the one covered by STED). Therefore it is important to have proper mappings in place (e.g. vs STED or 510k)
  • All document should be considered – not only those which are used for “submission” à model should include all documents related to medical devices which could be kept in EDMS (e.g. quality documents as well)
02a STED vs RPS

  • double check the RPS against current STED structures (IVD & nIVD)
 all
STED vs US 510k

  • US 510k – Young will make a comparison between STED and 510k
 Young Liu
Decision taken is to continue with the RPS based model, while keeping cross-reference with STED and 510k
02b Sheet - RPS_RM_Sort by Group should be break-down to individual xls sheets per Domain. Current Domains:

  • Regulatory/Admin,
  • Prescribing Information /Labeling,
  • CMC /Technical/Quality & Mnf/

    • •Clinical (includes also non-clinical attributes)

    		 B. Casselberry
    02c Proposed artifact names shold 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 serveral 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 Mode Suggestion to introduce additional column(s) for definition of terms – to standardise and to have common understanding. ongoing
    Consider differentiation for Clinical & Non-Clinical documents
    05 How to improve the visibility of the team and the initiative. Spread the info around – list of potential members / contributors all ongoing
    06 Webex – technical issue with voice quality dial-in option should be investigated R. Braun
    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
    http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n011-2008-principles-safety-performance-medical-devices-080221.pdf
    • Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, March 17th, 2011
    http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n063-2011-summary-technical-documentation-ivd-safety-conformity-110317.pdf
    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)
    http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-nivd-toc.pdf
    • In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)
    http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-ivd-toc.pdf