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Special Sessions

Special sessions are very small and specialized events to be held during the conference as a set of oral and poster presentations that are highly specialized in some particular theme or consisting of the works of some particular international project. The goal of special sessions (minimum 4 papers; maximum 9) is to provide a focused discussion on innovative topics. All accepted papers will be published in a special section of the conference proceedings book, under an ISBN reference, and on digital support. All papers presented at the conference venue will be available at the SCITEPRESS Digital Library. SCITEPRESS is a member of CrossRef and every paper is given a DOI (Digital Object Identifier). The proceedings are submitted for indexation by SCOPUS, Google Scholar, DBLP, Semantic Scholar, EI and Web of Science / Conference Proceedings Citation Index.

Special Session on European Regulations for Medical Devices: What Are the Lessons Learned after 1 Year of Implementation? - ClinMed 2024

Paper Submission: December 31, 2023 (expired)
Authors Notification: January 9, 2024 (expired)
Camera Ready and Registration: January 17, 2024 (expired)


Sylvia Pelayo
Thierry Chevallier
Norbert Noury
University of Lyon

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.