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Contact

Marlène Durand

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Contact

Linkedin biotis-bordeaux

Secretary Email

33 (0)5 57 57 14 88

Bioingénierie Tissulaire (BioTis)       

Physical Address:

Batiment BBS (Bordeaux Biologie Santé), 5e étage

2, rue du Dr Hoffmann Martinot,

33000, Bordeaux, France

Mailing Address:

Université de Bordeaux, Campus Carreire

146, rue Léo Saignat, Case 84,

33076, Bordeaux Cedex, France

Methods for Assessment of Safety and Performance of biomaterials in the perspective of a clinical trial

Abstract

Reference

Project Leader

MDR 2017/745 CE [1] has established the safety and performance requirements to commercialize a Medical Device (MD) on the European market. These requirements are based upon the class of risk of the MD and its claims. The French Competent Authority ANSM asks for the same level of demonstration of safety for authorizing a clinical investigation with a new MD. In this context, a researcher needs to be informed and guided in the development of his/her new biomaterial. The objective is to gather the guarantees of safety and performance with the appropriate quality level and timeline.

This approach implies good knowledge of the regulation but also of the applicable standards, the methodologies and documentation writing.

Dr Marlène DURAND, as both member of BIOTIS and CIC IT (CIC1401, CHU Bordeaux ; Innovation biomédicale, recherche de biomateriaux avec le CHU de Bordeaux : le CIC-IT. Aquitaine - France), serves the researchers and clinicians community (see exemples below [2 to 8]) towards this pathway from fundamental/experimental research to the clinical investigation.


▷Règlement - 2017/745 - FR - EUR-Lex

▷Charlotte Garot, Sarah Schoffit, Cécile Monfoulet, Paul Machillot, Claire Deroy, Samantha Roques, Julie Vial, Julien Vollaire, Martine Renard, Hasan Ghanem, Hanane El-Hafci, Adeline Decambron, Véronique Josserand, Laurence Bordenave, Georges Bettega, Marlène Durand, Mathieu Manassero, Véronique Viateau, Delphine LogeartAvramoglou, and Catherine Picart. 3D-Printed Osteoinductive Polymeric Scaffolds with Optimized Architecture to Repair a Sheep. Metatarsal Critical-Size Bone Defect. Adv. Healthcare Mater. 2023, 2301692

▷ Fenelon M, Etchebarne M, Siadous R, Grémare A, Durand M, Sentilhes L, Catros S, Gindraux F, L'Heureux N, Fricain JC. Comparison of amniotic membrane versus the induced membrane for bone regeneration in long bone segmental defects using calcium phosphate cement loaded with BMP-2. Mater Scien Eng C 2021May

▷de Gabory L, Boudard Ph, Bessède JP, Maillard A, Lacomme S, Gontier E, Durand M, Fricain JC, Bénard A, Bordenave L. Multicenter pilot study to assess a biphasic calcium phosphate implant for functional and aesthetic septorhinoplasty. Facial Plast Surg Aesthet Med. 2020 Jul 16.

▷Fenelon M, Etchebarne M, Siadous R, Grémare A, Durand M, Sentilhes L, Torres Y, Catros S, Gindraux F, L'Heureux N, Fricain JC. Assessment of fresh and preserved amniotic membrane for guided bone regeneration in mice. J Biomed Mater Res A. 2020 Apr 21.

▷Luc G, Charles G, Gronnier C, Cabau M, Kalisky Ch, Meulle M, Bareille R, Roques S, Couraud L, Rannou J, Bordenave L, Collet D, Durand M. Decellularized and matured esophageal scaffold for circumferential esophagus replacement : proof of concept in a pig model Biomaterials. Biomaterials, 2018; 175:1-18

▷Denost Q, Pontallier A, Buscail E, Montembault A, Bareille R, Siadous R, Durand M, Delmond S, David L, Bordenave L. Colorectal wall regeneration resulting from the association of chitosan hydrogel and stromal vascular fraction from adipose tissue. J Biomed Mater Res A. 2018 Feb;106(2):460-467

▷Aussel A, Thébaud NB, Bérard X, Brizzi V, Delmond S, Bareille R, Siadous R, James C, Ripoche J, Durand M, Montembault A, Burdin B, Letourneur D, L'Heureux N, David L, Bordenave L.  Chitosan-based hydrogels for developing a small-diameter vascular graft: in vitro and in vivo evaluation. Biomed Mater. 2017 Oct 3;12(6):065003