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Special Session
Special Session on
Dealing with the Change in European Regulations for Medical Devices - ClinMed 2022

9 - 11 February, 2022

Within the 15th International Joint Conference on Biomedical Engineering Systems and Technologies - BIOSTEC 2022


CHAIR

SCOPE

The new European regulation (EU MDR 2017/745) will enter into force on May 26, 2021. This new regulation sets forth new, improved rules to strengthen clinical evidence, particularly for high-risk medical devices for which a clinical study is mandatory. Given the wide range of medical devices available on the market and their countless variations in design features, treatment goals and targeted patient groups, setting a single standard study protocol seems unfeasible.This special session will cover efforts to build clinical evidence in accordance with the new regulations. We accept submissions covering all phases of the development cycle of a new medical device, from preliminary study confirming proof of concept to post-market clinical follow-up (real-world data) as well as in silico trials, first survey clinical in humans, medico-economy or usability study.

TOPICS OF INTEREST

Topics of interest include, but are not limited to:
  • Co-Design with End-Users
  • Human Factor Engineering
  • High Risk Medical Device
  • Clinical Investigation on Medical Device

IMPORTANT DATES

Paper Submission: November 26, 2021 (expired)
Authors Notification: December 14, 2021 (expired)
Camera Ready and Registration: December 22, 2021 (expired)

SPECIAL SESSION PROGRAM COMMITTEE

Fréderic Barbot, Raymond Poincaré Hospital, APHP, France
Thierry Chevallier, CHU NImes, France
Hugo Ferreira, Instituto de Biofisica e Engenharia Biomédica, Portugal
Thomas Lihoreau, CHU Besançon, INSERM CIC 1431, Centre d'Investigation Clinique, France
Sylvia Pelayo, Tech4Health/F-CRIN, France
Bruno Wacogne, FEMTO-ST, UMR CNRS 6174, 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, Microsoft Academic, 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 2022
e-mail: biostec.secretariat@insticc.org
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