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Special Session
Special Session on
European Regulations for Medical Devices: what are the lessons learned after 1 year of implementation?
 - ClinMed 2023

16 - 18 February, 2023 - Lisbon, Portugal

Within the 16th International Joint Conference on Biomedical Engineering Systems and Technologies - BIOSTEC 2023


CO-CHAIRS

Norbert Noury
University of Lyon
France

 
Brief Bio
Norbert Noury is a Full Professor covering Electronics and Physics in Medical devices and researcher in Biomedical Sensors team at INL-INSA Lyon where he developed activities in the fields of eHealth, connected health sensors, ambient assistive living environments. He is currently Director of the Master in Regulations of Medical devices at Polytech'Lyon School of Engineering, Director of the BSc in Medical Technologies at IUT University Lyon 1. He also launched a Living Lab for Health and developed Wearable non-invasive Smart Sensors for continuous monitoring of actimetrics, fall detection, thermal measurement, blood pressure. He is also an entrepreneur who contributed to launching 2 Start Ups, exploiting his work and (15) patents. He guided 20 PhD students, authored or co-authored more than 200 scientific papers (h index 36), and is a recognized expert at the European Commission. He is also frequently involved in the organization committees of international scientific events.
Sylvia Pelayo
Tech4Health/F-CRIN
France

 
Brief Bio
Dr. 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.
Thierry Chevallier
CHU NImes
France

 
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

SCOPE

The new European regulation on medical devices applies from May 26, 2021, after a four-year transition period, and has been strengthened in several areas. In particular, the requirements for manufacturers before placing a medical device on the market have been strengthened in order to put in place clinical evaluations and investigations to ensure the effectiveness and safety of the use of these devices for the benefit of the patient. One year after its implementation, what lessons can be learned? What initiatives should be taken? What are the shortcomings or gaps? Are the specificities of DM in digital health understood? Are the specificities of border DMs (drugs, cosmetics) easy to manage? How is the clinical evidence built in compliance with this regulation? We accept submissions covering all phases of the development cycle of a new medical device, from the preliminary study confirming the proof of concept to the post-market clinical follow-up (real-world data), including in silico testing, first-in-man clinical investigation, medico-economics or usability study.

TOPICS OF INTEREST

Topics of interest include, but are not limited to:
  • Clinical Investigation on Medical Devices
  • Software Medical Devices
  • Human Factors engineering for Medical Devices
  • Borderline Medical Devices

IMPORTANT DATES

Paper Submission: December 22, 2022
Authors Notification: January 10, 2023
Camera Ready and Registration: January 18, 2023

SPECIAL SESSION PROGRAM COMMITTEE

Available soon.

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

SECRETARIAT CONTACTS

BIOSTEC Special Sessions - ClinMed 2023
e-mail: biostec.secretariat@insticc.org
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