Meeting minutes 18.June.2015 - Device Ref Model Forum - Submission Reference ModelSubmission Reference Model

Meeting minutes 18.June.2015 (1 reply)

9 years ago

Romuald 9 years ago

Meeting Purpose	DIA EDM Reference Model - Devices
Meeting Date	21.05.2015
Meeting Time	17:00 (CET) - Europe Time (Rome, GMT+01:00)
Meeting Location	Webex
Meeting Facilitator	Renato Rjavec
Meeting Attendees	Company	Name
	Impact Systems	Cheryl Lewis
	independent	Steve Scribner

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	Note: a couple of participants has joined only, probable due to ongoing DIA event.	All	Done
01	STED Structure vs RPS Structure	(see previous minutes from 07.May.2015)		Done
02	Devices reference Model	(see previous minutes from 07.May.2015)		Done
		(see previous minutes from 21.May.2015)	All	Done
02a		(see previous minutes from 21.May.2015)	Yong	Done
02a.a		RPS vs. US 510k mapping (see previous minutes from 21.May.2015)	Yong	Ongoing
02b		Brooke prepred break-down sheets per Domain.Metod filled the missing non-clinical items (see also 04a)	Brooke	Done
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 Model	Suggestion to introduce additional column(s) for definition of terms – to standardise and to have common understanding.		Ongoing
		Decision was made to use the Excel format as leading format and if required upload to the MindMap tool (eg. For visualization) (see previous minutes from 21.May.2015)	All	Done
04a		Try to add additional columns and assess/discuss the complexity with the team	Metod	Ongoing
		Consider differentiation for Clinical & Non-Clinical documents	Metod	Done
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 -MEDTECHEUROPE (See links below)	Romuald B.In progress	Ongoing
06	Webex – technical issue with voice quality	dial-in option should be investigated	Romuald B.	Ongoing
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 (http://imdrf.org/consultations/cons-rps-atg-imdrf-toc-150409.asp )		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 oppinion was to keep all the things in one sheet to facilitate consistency.
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.

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

Medical Devices Forums and Associations

International Medical Device Regulators Forum

http://imdrf.org/index.asp

Advanced Medical Technology Association

http://advamed.org

MedTech Europe