The New European Directive 2007/47 and the Update ISO 10993 Standard for Medical Devices Vincent Legay Namsa - Biomatech Email: v.legay@biomatech.fr
|
Biography Dr Vincent Legay was trained as a biologist, obtaining his PhD from the University of Lyon. He specialized in biotechnology (cell culture and microbiology). He has spoken and provided written articles in international newspapers and conferences. He previously worked at Biomatech-Namsa as a Laboratory Supervisor and toxicology specialist, providing advisory services to clients. Today, he serves as European Sales Manager for NAMSA group. Company Profile NAMSA is a worldwide company dedicated to the clinical and pre-clinical evaluation of medical devices. The headquarter is based in Northwood (Ohio) and the European division of NAMSA, BIOMATECH, is based in Lyon (France). NAMSA is a 450 employees company, including 100 employees in its European facilities, BIOMATECH with more than 50 years experience in the area of medical devices evaluation. NAMSA clinical evaluation offering is made of clinical trials or clinical data evaluation through the literature route. NAMSA pre-clinical offering is made of chemical characterization testing, biocompatibility testing, microbiology and sterility assessment testing, as well as advisory services all along the processes in order to assist manufacturers to optimize their regulatory strategies for file submissions to any authorities in the world (FDA, KFDA, SFDA, CE, MHLW …)
|
Abstract Medical device manufacturers are facing challenges when submitting their technical files to authorities. Particularly, the assessment of toxicological safety is based on the evaluation of biocompatibility of the medical devices, according to the ISO 10 993 standard. The part 1 of this standard has recently been updated, in order to emphasize the rationales and risk analysis the manufacturers have to consider to prepare their biological evaluation plan and toxicology assessment. The goal of that session is to review the main changes of this ISO 10 993-1 and how the expectations impact the regulatory strategy. We’ll also focus on a recent major change in the EU MDD 2007/47 providing additional details on what are the expectations are for medical devices in order to full fill the European requirements in terms of pre-clinical and clinical evaluation.
|
