Meeting minutes - 08.Oct.2015 - Device Ref Model Forum - Submission Reference ModelSubmission Reference Model

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
	INFOTEHNA	Eric Haase
	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		Ongoing
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 -03 -04a -09b -10 Romuald will take the 1^st 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 -MEDTECHEUROPE (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 (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 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) -Cardinality		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		Ongoing

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