ClinMed 2022 Abstracts

Area 1 - ClinMed

Full Papers

Paper Nr:	4
Title:	The Role of Massive Databases in the Post-market Clinical Follow-up of Medical Devices
Authors:	Marion Burland and Thierry Chevallier
Abstract:	With the application of new European regulations on medical devices in May 2021, the requirements for clinical evaluation have been strongly reinforced. Post-marketing clinical follow-up is now a key activity for manufacturers to keep their medical devices on the market. The use of material-epidemiology studies and real-life databases has multiple strengths and advantages. However, the weaknesses and limitations identified do not yet allow manufacturers (especially small and medium-sized companies) to fully utilize these tools for post-market clinical follow-up. Yet certain technological and regulatory developments already implemented, and to be implemented over time, suggest that these tools could play a crucial role in the clinical monitoring of medical devices in the future. In order to better define the future use of real-life data in post-market clinical follow-up activities, a comprehensive update of technological and regulatory surveillance is still required.
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Paper Nr:	5
Title:	Analysis of Impact of European Medical Device Regulation and Brexit on the Regulatory Approaches in a Clinical Investigation Study on a New Class III Medical Devices Conducted in Europe and United Kingdom
Authors:	Candice Houg, Thomas Lihoreau, Martina Hennessy, Helene Esperou, Rachel Benamore, Jean Palussiere and Lionel Pazart
Abstract:	The evolution of technological innovations and medical devices requires particular reflections in terms of regulation. In order to harmonise practices between European countries and to reinforce clinical investigations, the European Regulation on medical devices 2017/745 has come to give a regulatory framework to the world of devices. A summary of the regulatory approaches for a clinical investigation of a new class III device conducted in France, Ireland and England is proposed in this article to illustrate the complexity of the processes, ending with an example. This illustrates the impact of the EU regulation and Brexit on the conduct of clinical investigations.
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Paper Nr:	6
Title:	Is Usability Engineering Anticipation Possible during the Initial Research Actions? An Example with the R-Link in Vitro Self-monitoring Device
Authors:	K. Charrière, C. L. Azzopardi, S. Pelayo, M. Nicolier, T. Lihoreau, F. Bellivier, E. Haffen and B. Wacogne
Abstract:	Bipolar disorders are severe and complex psychiatric disorders and lithium remains one of the most effective drugs for relapse prevention. Despite its effectiveness, prescription of lithium therapy can be complicated because of its narrow therapeutic range. Furthermore, adherence to treatment is generally low. One means of improving adherence would be to make the patient an actor of his/her treatment. The possibility to control the lithium level with a device that can be used at home would favor this involvement. Although the main part of the work to produce a device is research and development, regulatory analysis, including usability, should not be neglected. Indeed, some design choices should be made taking into account usability constraints. This ensure the fabrication of a device which will be safe, effective and well accepted by the intended users. In this conference, we present actions taken in this direction during the R-Link project.
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Short Papers

Paper Nr:	1
Title:	Post-market Clinical Follow-up (PMCF) GAP Analysis for Legacy Devices Class III between the Medical Device Directive (MDD 93/42/EEC) and the Medical Device Regulation (MDR 2017/745)
Authors:	Marina Makeenko and Thierry Chevallier
Abstract:	The passage from the MDD 93/42/CEE to the MDR 2017/745 remains a big challenge for the manufactures. The interpretation of the regulatory requirements stays unclear and can differ from one source to another, especially when it comes to the clinical evaluation. Will the data collected under the MDD 93/42/CEE be sufficient to prove the safety and security of the device? Under the directive each country was establishing its own requirements for the conduct of the studies. The MDR has standardized these rules, so that all the clinical data collections follow the same pathway. We will examine the PMCF of the class III devices already CE marked under the directive (legacy devices) to find out if the new requirements will be asked to be in compliance with the MDR. A Gap analysis between the MDD and MDR will help us in our research. A matrix in the form of a questionnaire will be established to help us verify compliance of the PMCF under the MDR.
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Paper Nr:	2
Title:	Combined Medical Devices: Which Classification for These Borderline Products and Which Consequences for the Manufacturers - About a Use Case in Skin Healing Area
Authors:	Vaissière Anaïs and Chevallier Thierry
Abstract:	Skin healing is a rapidly expanding field, especially with the growing needs of an aging population and the increase in chronic pathologies (diabetes, venous ulcers, bedsores etc...). In order to offer ever more adapted solutions, manufacturers are competing in ingenuity to propose innovative medical devices that meet the expectations of patients, caregivers and the healthcare system. These developments raise many questions, particularly with regard to the classification of devices in the various risk classes and the naming of these wound healing devices. This article will focus on combined medical devices with the difficulties they pose for manufacturers and health authorities in terms of development, financial investment, risk-taking and the difficulty of classifying these so-called borderline products in the medical device universe.
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Paper Nr:	7
Title:	Regulatory Approaches for a Retrospective Multicentre Multinational Study on Data: An Example Conducted in France, Ireland and England
Authors:	Candice Houg, Thomas Lihoreau, Martina Hennessy, Kristina Mouyabi, Rachel Benamore, Jean Palussiere, Julien Behr and Lionel Pazart
Abstract:	Retrospective studies are studies that easily provide data on a population. As the data are already available in the medical records, the collection and analysis of the results is faster. These studies are particularly valuable in the post-marketing clinical follow-up of medical devices. They allow manufacturers to easily and proactively obtain safety and performance data. The regulatory procedures associated with this type of study also appear to be much less burdensome than a prospective study. We propose to illustrate the procedures through a multinational retrospective study conducted in France, England and Ireland.
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