Tuesday, May 16, 2023
Announced by Regen Lab, a global medical device company specializing in the research, development, registration, manufacture and commercialization of proprietary tissue engineered products , the market-leading medical devices REGENKIT®, CELLULAR MATRIX fig® and Arthrovisc® have received CE certification in accordance with EU Regulation 2017/745 on medical devices (MDR).
REGENKIT® is a preparation of platelet-rich plasma (PRP), CELLULAR MATRIX fig ®, , a combination of PRP and hyaluronic acid (HA), and Arthrovisc®, syringes filled with HA.
Based on the audit of the quality management system and the technical documentation, these new CE certificates, issued by the BSI notified body to Regen Lab SA (EU authorized representative Regen Lab France SAS), are all valid for five years. The period of validity begins on April 25, 2023 and expires on April 24, 2028.
The EU MDR 2017/745 regulation, which is imposed on all manufacturers and distributors operating in the European Union and has been in force in the European Union since May 26, 2021, is intended to replace the existing European directives on medical devices (MDD 93/42/EEC) by 2028. necessarily replace. These EU regulations on medical devices aim to create a modern and more robust legal framework to protect public health and patient safety. With this certification, the amount of technical and clinical validation data required for medical devices in the EU has increased significantly to meet demands for better traceability and transparency of safety.
Looking towards the EU MDR certification of its products, Regen Lab has successfully renewed its ISO13485:2016 and MDSAP certifications with a quality system that meets the requirements of the European MDR regulation EU 2017/745 of December 2022.
The certifications obtained strengthen Regen Lab's competitive position in the market for PRP alone and in combination with HA.
Regen Lab's autologous tissue engineering solutions are based on an extemporaneous preparation of PRP from the patient's own blood and a combined therapy (PRP coupled with HA).
Regen Lab is a vertically integrated group with extensive expertise in research and development, regulatory affairs and manufacturing. To date, Regen Lab's patented technologies* are available in over 90 countries worldwide and are used to treat patients in various therapeutic areas (musculoskeletal, skin aesthetics, wound care and urogenital). This led to the publication of over 200 clinical studies. The company's products will be manufactured at the Group's production sites in Le Mont sur Lausanne (Switzerland), Brooklyn (New York, USA) from 2022 and in Les Ulis (Paris region, France) from the third quarter of 2023.