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
Mainstay Medical Announces Coverage Recommendation from the International Society for the Advancement of Spine Surgery (ISASS) for ReActiv811.12.2025 15:30:00 EET | Press release
Mainstay Medical Holdings plc today announced that the International Society for the Advancement of Spine Surgery (ISASS) has issued recommendations and coverage criteria for the use of restorative neurostimulation for the treatment of chronic mechanical low back pain associated with multifidus muscle dysfunction. ReActiv8® restorative neurostimulation is the only therapy approved in the United States, Europe and Australia for this indication. The Statement, which affirms ISASS’ support for coverage by payers of implantable restorative neurostimulation in appropriately selected patients, was published in the December issue of the International Journal of Spine Surgery and can be accessed here: https://www.ijssurgery.com/content/early/2025/12/10/8833. The Statement reflects the growing body of clinical evidence supporting the use of ReActiv8, as well as recent developments in diagnostic coding and reimbursement pathways since ISASS’ 2023 Statement on Restorative Neurostimulation for Chr
SLB Enters Collaboration Agreement to Accelerate New Digital Solutions11.12.2025 15:28:00 EET | Press release
Global energy technology company SLB (NYSE: SLB) signed a strategic collaboration agreement with Shell to develop digital and AI solutions that drive measurable performance and efficiency gains across upstream operations for the company and the wider industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211832051/en/ The collaboration has the ambition to develop agentic AI-powered solutions that will accelerate and amplify the capabilities of technical experts and decision makers. The aim is to develop and deploy an open data and AI infrastructure that unifies data and workflows across subsurface, well construction and production in a secure digital environment, using SLB’s Lumi™ data and AI platform. The collaboration has the ambition to develop agentic AI-powered solutions that will accelerate and amplify the capabilities of technical experts and decision makers. The aim is to develop and deploy an open data and AI i
Tahoe Therapeutics Selects Parse Biosciences’ GigaLab to Generate 300 Million Single Cell Profiles for Large-Scale Perturbation Atlas11.12.2025 15:00:00 EET | Press release
Parse Biosciences, a leading provider of accessible and scalable single cell sequencing solutions, today announced that Tahoe Therapeutics has selected Parse’s GigaLab to generate data for its upcoming 300M cell project. Tahoe will use its proprietary Mosaic technology to generate samples consisting of 300M cells from large arrays of disease models, genetically or chemically perturbed. Under this agreement, Parse will apply its Evercode™ chemistry and high-throughput automation to these samples to deliver the largest perturbation-focused single cell dataset ever produced. Parse’s GigaLab, designed specifically for million- to hundred-million-cell projects, has rapidly become an industry benchmark for large-scale, reproducible single cell data generation. The facility integrates high-capacity liquid handling, standardized workflows, and end-to-end QC to enable dataset sizes previously unattainable for most research organizations. The Tahoe project represents one of the largest sequencin
Xsight Labs X2 Switch to Enable Next-Generation Starlink Satellites and Deliver Gigabit Connectivity11.12.2025 15:00:00 EET | Press release
Xsight Labs, an innovator in high-performance connectivity silicon, today announced that Starlink, the world’s most advanced satellite constellation in low-Earth orbit, delivering broadband, will leverage the Xsight X2 Programmable Ethernet switch to serve as the high-speed networking core for its next-generation Starlink V3 satellites. Each V3 Starlink satellite is designed to deliver more than 1 terabit per second (Tbps) of fronthaul throughput, more than 10× the capacity delivered by Starlink V2 Mini satellites, and about 160 gigabits per second (Gbps) of uplink capacity. Starlink’s global broadband service depends on processing and routing large volumes of real-time data, including inter-satellite optical link traffic, orbital mesh routing decisions, adaptive beam steering, and the high-throughput downlink required to serve its customers. The X2 delivers 12.8 Tbps of switching capacity using state-of-the-art 100G SerDes and TSMC’s N5 process, providing a power-efficient, ultra-low-
Payments Leaders Unprepared for 2026 Disruption, Warns ACI Worldwide11.12.2025 14:36:00 EET | Press release
Most global payments leaders lack a clear roadmap to navigate the seismic changes coming in 2026 , according to the latest Top Ten Payments Predictions from ACI Worldwide (NASDAQ: ACIW), an original innovator in global payments technology. With AI-driven intelligence, next-gen authentication, new regulatory frameworks, and soaring demand for instant, embedded, and secure payments, the industry is entering an era of structural disruption. However, ACI’s recent report Payments in Transition: Leadership in an era of transformation reveals that only 36% of payments executives have a clear long-term modernization roadmap, leaving many without a strategic vision for transformation. “In 2026, payments disruption won’t be incremental—it will be structural,” said Philip Bruno, Chief Strategy and Growth Officer at ACI Worldwide. “Real-time is now the baseline, digital assets are entering regulated ecosystems, and AI is transforming every layer of the value chain. Our research is a clear warning:
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