Special Session
Special Session on
European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of Implementation? -
ClinMed
2024
21 - 23 February, 2024 - Rome, Italy
Within the 17th International Joint Conference on Biomedical Engineering Systems and Technologies - BIOSTEC 2024
* CANCELLED *
CO-CHAIRS
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Sylvia Pelayo
Tech4Health/F-CRIN
France
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Brief Bio
Sylvia Pelayo, Ph.D. is a full professor in cognitive ergonomics, director of the Evalab and co-director of the Clinical Investigation Center for Innovative Technologies (CIC-IT) 1403 in Lille. She promotes at a national level the improvement of the services and products generated by the new technologies in healthcare in compliance with regulations and with all phases of evaluations to ensure safety, acceptance and usefulness of technologies. At a national level, she is the leader of the French research network on cognitive ergonomics dedicated to healthcare technologies and services. Sylvia Pelayo coordinates the Tech4Health network which is a component of the French national infrastructure of clinical research (F-CRIN) dedicated to medical devices investigation.
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Thierry Chevallier
BESPIM, CHU NImes
France
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Brief Bio
Thierry Chevallier (Md-Phd) is a Hospital Practitioner at the University Hospital of Nimes, Methodologist and Clinical Epidemiologist in the Public Health and Epidemiological department (BESPIM). He is Coordinator of the Institute for the Evaluation of Medical device (IDIL) and a member of the UMR 1302 Institute Desbrest of Epidemiology and Public Health, INSERM, University of Montpellier.
He is also Vice President of the Ethics Committee of Montpellier and coordinator of the national Tech4Health network, a component of the F-CRIN infrastructure specialized in the evaluation of medical devices
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Norbert Noury
University of Lyon
France
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Brief Bio
Norbert Noury is a Distinguished Professor at University of Lyon, France. His lectures cover Electronics and Physics in Medical devices and his research interests are in eHealth, connected health sensors, Ambient assistive living environments. After a MSc in Electronics (Grenoble University, 1985), he was R&D engineer in several industrial companies during 8 years. He then defended his PhD in Medical Telematics (1992) and joined the University of Grenoble (1993), where he initiated a new field of researches in Health Smart Homes and wearable health sensors and he created and directed his own research group at laboratory TIMC in Faculty of Medicine Grenoble (1998-2008). In 2008 he moved to University of Lyon, where he took various responsibilities - Director of the Department of Biomedical Engineering at Polytech'Lyon School of Engineering, Director of the Master in Regulations of Medical devices, Director of the BSc in Medical Technologies at IUT Lyon 1. Since 2008, he was also with the Biomedical Sensors research group at INL-INSA Lyon where he launched a Living Lab for Health and developed several innovative wearable non-invasive smart sensors for continuous monitoring of humans (actimetrics, fall detection, thermal measurement, non-invasive blood pressure). He is also an entrepreneur who contributed to launching 2 Start Up, exploiting his works and (15) patents. He guided 21 PhD students, authored or co-authored more than 250 scientific papers (H-index 38). He is an expert and reviewer at the European Commission, ESF, CRSNG. He is an active member of the French Chapter IEEE EMBS (President 2015-19, secretary 2013-15, VP since 2019). He was one of the founders of the “Groupement National de Recherche Biomédicale” GDR STIC-Santé in which he led the “wearable health sensors” group (2002-14). He also is frequently involved in the organization committees of international scientific events (General Chair IEEEHealthcom2010 in Lyon and IEEE-Healthcom2018 in Ostrava, local organizing committee IEEE-EMBC2007 in Lyon, pHealth2011 in Lyon, member of the steering Committee of the IEEEHealthcom conference from 2010 to 2020).
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SCOPE
The requirements for placing medical devices on the market in Europe have been strengthened through European regulations (MDR 2017/745 & 2017/746). Following those regulations, evidence generation is now a cornerstone during the entire development life cycle for the devices to meet safety and performance requirements for market access and to fulfill post-market responsibilities. A methodological approach to define, determine and update the state of the art for different device technologies is needed. Registries and other sources of real-world data for demonstration of regulatory compliance both pre- and post-market can be used. Relevant quantitative and qualitative methodologies for integrating evidence derived from various data sources in the preclinical and clinical evaluation are now essential. Additionally, a particular attention must be paid to highly innovative devices, to high-risk devices or to digital devices, bearing in mind that regulations in relation to artificial intelligence are currently evolving. Furthermore, beyond methodological issues, challenging regulatory issues also concern the need to increase the number of regulatory affairs profiles, relieve the workload of notified bodies and support companies in upgrading their certificates.
Hence, we welcome scientific communications on research encompassing any of the mentioned aspects.
TOPICS OF INTEREST
Topics of interest include, but are not limited to:
- (In Vitro) Medical Devices
- Regulations
- Digital Medical Devices
- Health IOT
- AI in Medical Devices
- Education
IMPORTANT DATES
Paper Submission:
December 31, 2023 (expired)
Authors Notification:
January 9, 2024 (expired)
Camera Ready and Registration:
January 17, 2024 (expired)
SPECIAL SESSION PROGRAM COMMITTEE
Fréderic Barbot,
Inserm, Clinical Investigating Center 1429, Raymond Poincaré Hospital, APHP, France
Thomas Lihoreau,
Clinical investigation center CIC INSERM 1431, CHU Besançon, INSERM CIC 1431, Centre d'Investigation Clinique, France
(list not yet complete)
PAPER SUBMISSION
Prospective authors are invited to submit papers in any of the topics listed above.
Instructions for preparing the manuscript (in Word and Latex formats) are available at: Paper Templates
Please also check the Guidelines.
Papers must be submitted electronically via the web-based submission system using the appropriated button on this page.
PUBLICATIONS
After thorough reviewing by the special session program committee, all accepted papers will be published in a special section of the conference proceedings book - under an ISBN reference and on digital support - and submitted for indexation by SCOPUS, Google Scholar, DBLP, Semantic Scholar, EI and Web of Science / Conference Proceedings Citation Index.
SCITEPRESS is a member of CrossRef (http://www.crossref.org/) and every paper is given a DOI (Digital Object Identifier).
All papers presented at the conference venue will be available at the SCITEPRESS Digital Library