Regen Lab Announces the Obtention of the New CE Certification Under Medical Device Regulation (EU MDR 2017/745) Validating the Safety and Performance of Its Proprietary Best-in-class PRP Solutions, Alone or Combined With Hyaluronic Acid
Regen Lab, a global commercial-stage medical technology company specializing in the research, development, registration, manufacturing and commercialization of proprietary tissue engineering products announces that its best-in-class medical devices REGENKIT®, CELLULAR MATRIX fig® and Arthrovisc® have obtained the CE certification under the 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®, HA filled syringes.
Based on the examination of its Quality Management System and Technical Documentation, these new CE certificates delivered to Regen Lab SA (EU authorized representative Regen Lab France SAS) by the notified body BSI are all valid for five years with a starting validity date on April 25, 2023, and an expiry date on April 24, 2028.
Imposed on all manufacturers and distributors operating in the European Union, the EU MDR 2017/745, applicable since May 26, 2021, in the European Union, is meant to mandatorily replace by 2028 the existing European Medical Device Directives (MDD 93/42/EEC). These EU regulations on medical devices aim at establishing a modern and more robust regulatory framework to protect public health and patient safety. This certification has considerably increased the amount of technical and clinical validation data required on medical devices across the EU, to address the need for a better traceability and transparency in safety.
In relation to the EU MDR certification of its products, Regen Lab successfully renewed its ISO13485:2016 and MDSAP certifications with a Quality Assurance System meeting the requirements of the European MDR EU 2017/745 Regulation in December 2022.
The certifications obtained reinforces Regenlab’s competitive position in the PRP market alone and in combination with HA.
Regen Lab autologous tissue engineering solutions are based on an extemporaneous preparation of PRP from the patient’s own blood and combined therapy (PRP combined with HA).
Regen Lab is a vertically integrated group with extensive R&D, regulatory and manufacturing expertise. To date, Regen Lab’s patented technologies* are available in over 90 countries worldwide and have been used to treat patients in various therapeutic areas (musculoskeletal, dermo-esthetics, wound care and urogenital) leading to the publication of over 200 clinical studies projects. The Company’s products are manufactured in the Group factories in Le Mont sur Lausanne (Switzerland), Brooklyn (New York, USA) since 2022, and in Les Ulis (Paris region, France) starting from Q3 of 2023.
More info about Medical Devices Regulation: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
About Regen Lab
Based in Mont-sur-Lausanne, Switzerland, Regen Lab is a global commercial-stage medical technology company specialized in the research, development, registration, manufacturing and commercialization of proprietary tissue engineering solutions. The Company's solutions are commercialized in more than 90 countries and generated total revenues of €40 million in 2022. The core technology of the Company focuses on the design of solutions for autologous platelet-rich plasma (PRP) based procedures, consisting in reinjecting the patient's own platelets into tissue lesions in order to stimulate tissue healing. The Company's original medical devices, commercialized primarily under the RegenKit brand, have been CE marked EU-MDR 2017/745 and approved by FDA and CFDA and are routinely used by physicians worldwide for the treatment of a wide variety of main indications currently including joint osteoarthritis, tendinopathies and dermo-esthetics. The Company's products are manufactured in the Group factories in Le Mont-sur-Lausanne (Switzerland), New York (USA) since Q3 2022 and Les Ulis (Paris region, France) starting Q3 2023, which the Company has built to meet its anticipated increasing demand for its new products.
More info about RegenLab: https://www.regenlab.com
*For a list of Regenlab’s patents see: https://www.regenlab.com/patents
Regenkit®, Cellular Matrix fig®, Arthrovisc, Regenlab®, Regenplasma®, Regencell®, RegenACR®, THT® are registered or pending trademarks of Regen Lab SA or RegenLab USA LLC.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230515005412/en/
Contact information
Daphné Van Diermen
Chief Operating Officer
ddiermen@regenlab.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
MarkLines Gen-AI Beta Version Released for Automotive Industry13.1.2026 02:00:00 EET | Press release
MarkLines Co., Ltd. (Headquarters: Minato-ku, Tokyo; President & CEO: Makoto Sakai; TYO:3901) announced its launch of the "MarkLines Gen-AI Beta Version," the new feature for B2B users in the automotive industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112383839/en/ "MarkLines Gen-AI Beta Version" can take questions in natural language and instantly give highly reliable, relevant data drawn from MarkLines’ extensive automotive database (Image: MarkLines Co., Ltd.) This AI-powered feature enables users to ask questions in natural language and instantly receive highly reliable, relevant data drawn from MarkLines’ extensive automotive database. Moreover, the system analyzes this information by leveraging the rich content across its platform and delivers clear, concise, text-based insights. By combining trusted data with advanced analytical capabilities through generative AI, this service represents a first-of-its-kind
Australian Defence Force Secures Satellite Communications on SES IS-2212.1.2026 23:30:00 EET | Press release
Satellite communications solutions provider SES will provide secure uninterrupted satellite communications to the Australian Defence Force (ADF) for a minimum of 16 years thanks to a new extended agreement. The service will be provided via the SES Intelsat 22 satellite and an ultra-high frequency (UHF) military communications payload. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112137182/en/ Assistant Secretary Space Systems Branch, Michael Hunt, formalizes contract negotiations for the through-life support of the IS-22 satellite with Rory Welch, senior vice-president of service delivery at SES Space and Defense. Photos: Corporal Annika Smit Under the renewed arrangement, SES will reposition the IS-22 satellite to a new orbital slot specified by the ADF, continuing a mission that has been the cornerstone of Australia’s secure military communications since IS-22’s launch in 2012. SES will build a dedicated ground segmen
NetApp Appoints Paul Fipps to the Board of Directors12.1.2026 23:05:00 EET | Press release
NetApp® (NASDAQ: NTAP), the intelligent data infrastructure company, today announced that Paul Fipps, President of Global Customer Operations at ServiceNow, has joined its Board of Directors. The board now has ten directors, nine of whom are independent, and 50% of whom have been appointed within the last five years. Fipps brings more than 20 years of experience driving technology-enabled growth and customer transformation. At ServiceNow, he currently leads global sales, customer success, partner ecosystems, and field operations. He previously served as EVP of Worldwide Sales at ServiceNow and as President of Under Armour Connected Fitness and Chief Experience Officer at Under Armour, overseeing global direct-to-consumer, connected fitness, and digital experiences. He also previously served on the advisory board of Quantum Metric. Fipps holds a B.S. in Information Systems, an MBA from the University of Baltimore, and is a graduate of The Wharton School’s Advanced Management Program. “P
FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor12.1.2026 21:00:00 EET | Press release
Merck, a leading science and technology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) for pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor (TGCT). The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib. “With pimicotinib, we have an opportunity to significantly advance care for people living with TGCT, a painful and debilitating disease that has few effective and well-tolerated treatment options beyond surgery,” said David Weinreich, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “Based on clinical trial results showing not only a reduction in tumor burden, but also the ability to help alleviate symptoms like pain and stiffness in the global Phase 3 MANEUVER study
Fabentech receives Marketing Authorization for Ricimed®, an antidote against ricin poisoning12.1.2026 20:32:00 EET | Press release
Fabentech, a French biopharmaceutical company specializing in medical countermeasures against biological threats, today announces that it has been granted Marketing Authorization for Ricimed®, a treatment for ricin poisoning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112241557/en/ Ricimed - Fabentech Ricimed®, an antidote against one of the most toxic natural substances in the world In addition to supportive care, and in severe situations requiring immediate administration, Ricimed® represents a new therapeutic option for the management of acute ricin intoxication. Ricin, among the most dangerous naturally occurring substances, can cause death within hours or days regardless of the route of exposure, making it a major biological threat for many countries. Having demonstrated its ability to specifically target and neutralize ricin before irreversible damage occurs, Ricimed® is an antibody-based therapy relying on poly
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom