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
15.5.2023 15:00:00 EEST | Business Wire | Press release
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
Hollywood Chamber of Commerce Expands Into Luxury Hospitality20.7.2026 19:30:00 EEST | Press release
The Hollywood Chamber of Commerce, known for the iconic Hollywood Sign® and Hollywood Walk of Fame®, is expanding into luxury hospitality through a strategic partnership with The Scene Hotels & Resorts to launch Hollywood Hotels & Residences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720026178/en/ The Scene Hotels & Resorts, with 40+ years of combined expertise in hospitality, travel, and brand development, will lead the brand’s development and management. The partnership will bring the Hollywood lifestyle to luxury hotels and branded residences around the world, creating immersive destinations inspired by the world's entertainment capital. "This partnership represents far more than an expansion of the Hollywood brand—it reflects our vision of Hollywood as the world's premier hub for entertainment, creativity, and commerce," said Ron Frierson, President & CEO of the Hollywood Chamber of Commerce. "By deepening our in
Epic Flight Academy Agrees to Purchase up to 50 Pipistrel Voyager Aircraft, Supplementing Its Fleet of Trainers as It Supports Continued Pilot Training20.7.2026 18:38:00 EEST | Press release
Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today announced Epic Flight Academy as the launch customer for the Pipistrel Voyager during Textron Aviation’s press conference at EAA AirVenture 2026. The company has signed a purchase agreement for up to 50 Voyager aircraft, with an order for 10 initial deliveries beginning in 2027, and options for up to 20 additional aircraft in 2028 and 20 in 2029, supporting the continued expansion of its training fleet and growing demand for pilot training. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720003143/en/ Epic Flight Academy agrees to purchase up to 50 Pipistrel Voyager aircraft, supplementing its fleet of trainers as it supports continued pilot training (Photo Credit: Pipistrel, a Textron Inc. company and an affiliate of Textron Aviation Inc.) Epic Flight Academy is a Florida-based flight training provider offering FAA Part 141 and
New Pipistrel Voyager Brings Next Generation Training Capabilities and Access to Flight Schools20.7.2026 16:00:00 EEST | Press release
Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today introduced the Pipistrel Voyager, a next-generation training aircraft designed to expand capability for flight schools while maintaining the efficiency and simplicity owners and operators expect from Pipistrel. Purpose-built for evolving pilot training requirements, the Voyager is designed to align with anticipated Modernization of Special Airworthiness Certification (MOSAIC) regulations. This positions the aircraft to support broader training missions while improving access to pilot development. The aircraft is expected to enter into service in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720673571/en/ New Pipistrel Voyager brings next generation training capabilities and access to flight schools (Photo Credit: Pipistrel, a Textron Inc. company and an affiliate of Textron Aviation Inc.) The Voyager is making its world d
Expensify Launches Corporate Card in Europe20.7.2026 16:00:00 EEST | Press release
Expensify, Inc. (Nasdaq: EXFY), the easiest way to manage expenses, corporate cards, and travel, today announced that the Expensify Card is available to businesses of all sizes in the UK and select European markets, including Spain, Ireland, Poland, and the Netherlands. “The Expensify Card works quietly in the background to keep your business spend controlled, compliant, and ready for accounting,” said David Barrett, founder and CEO of Expensify. “It’s a preaccounting assistant that eliminates hours of reconciling transactions, chasing receipts, and reimbursing employees. One of our US customers, Pivot Bio, cut down on their expense report audit times by 90%. We can’t wait to share that same time savings with millions of businesses in the UK and EU.” Key benefits of the Expensify Card include: Real-time spend visibility: Transactions appear instantly in Expensify, so finance teams aren't waiting until month-end to see what was spent. Auto-categorization and receipt matching: Concierge
86% Of Enterprises Have Deployed AI Agents. Just 34% Trust Them, Boomi Study Finds.20.7.2026 16:00:00 EEST | Press release
Boomi, the data activation company for AI, today announced new research conducted by Forrester Consulting on behalf of Boomi showing that despite rapid enterprise adoption of AI agents, trust hasn't kept pace with ambition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720652115/en/ Boomi-commissioned independent study finds integration, not smarter models, separates enterprises that trust their AI agents from those stuck in “agentic chaos” The Forrester survey of 409 director-and-above IT and technology decision-makers across North America, Europe, and APAC found that 86% of organizations have moved beyond the AI agent pilot stage, yet just 34% say they trust the actions their AI agents are taking. Among organizations in a state of "agentic chaos" (the bottom quartile for operational readiness across governance, integration, API/MCP management, and other categories), 77% are moving into production anyway, exposing thems
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