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
Galderma Announces First Patient Enrollment in Study to Assess Nemolizumab in Adults With Chronic Pruritus of Unknown Origin11.12.2025 08:00:00 EET | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the first patient enrollment for its phase II study investigating the efficacy and safety of nemolizumab in treating patients living with Chronic Pruritus of Unknown Origin (CPUO). The first patient of the trial – which is taking place in the United States – was enrolled at Dr. Vlada Groysman’s site in Birmingham, Alabama. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251210261871/en/ CPUO is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause.1 It is a common condition and prevalent in nearly 30% of the elderly in certain populations, but despite its debilitating impact – with effects on sleep, mental health, and overall quality of life – there are currently no approved treatments.1,7 Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signa
Ant International and HSBC Test New Cross-Border Payments Solution Using Tokenised Deposits on Swift’s Network and Powered by ISO 2002211.12.2025 05:00:00 EET | Press release
Ant International, HSBC and Swift today have completed a successful Proof of Concept (POC) for the cross-border transfer of tokenised deposits using ISO 20022 standards. The initiative leverages Swift’s global messaging network and HSBC’s recently launched Tokenised Deposit Service, combined with Ant International’s blockchain technology. The POC marks a key milestone in Ant International, HSBC, and Swift’s efforts to help businesses unlock the full benefits of tokenisation for enhanced liquidity, programmable finance, and 24/7 real-time settlement. As part of this initiative, Ant International and HSBC successfully integrated Ant International’s in-house blockchain infrastructure with Swift’s networks, enabling real-time treasury management across borders through HSBC Singapore and Hong Kong, via HSBC’s Tokenised Deposit Service. With the introduction of a common protocol co-built with Swift and HSBC, this could remove the need for Ant International to establish individual bilateral a
Canva Unveils 2026 Design Trends: The Year of ‘Imperfect by Design’11.12.2025 00:52:00 EET | Press release
Canva, the world’s leading all-in-one visual communication platform, today unveiled its third annual Design Trends Report with bold predictions for creativity, social media and brand content in 2026. The company also unveiled a “Design DNA” feature, which offers Canva users a custom recap that celebrates their creative output in 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251210696597/en/ Canva Design DNA Trends from Creators, for Creators By analyzing design and search activity, expert insights from the Canva Designer Advisory Board, and a survey of 1,000 creators across the U.S. and Brazil, Canva has identified 10 design trends that will shape creative and design culture in 2026. The findings paint a clear picture: as creators embrace AI’s power, they also crave the human touches that make design feel personal. A New Creative Standard: Imperfect by Design As AI technology raises the baseline for what's possible, v
Audiencerate Achieves Google Customer Match Partner Status, strengthening its role as a Global Data Provider10.12.2025 23:40:00 EET | Press release
Audiencerate, an international technology company specializing in data activation solutions and platforms within the AdTech and MarTech sectors, has been officially awarded by Google as a Customer Match Upload Partner. This certification is granted to a restricted number of global operators (https://support.google.com/google-ads/answer/7361372?hl=en) authorized to manage and onboard first-party data into the Google Ads and DV360 ecosystem. The company strengthen its strategic partnership with Google by adding the Customer Match Upload Partner accreditation to its existing status as a certified Google Data Provider. This new credential enables Audiencerate to seamlessly integrate proprietary audience segments and data into Google’s advertising platforms. The combination of these two accreditations represents an exceptionalsituation in the international landscape and solidifies Audiencerate's position in the digital advertising market, which is increasingly reliant on first-party data. T
Defence, Security and Resilience Bank (DSRB) Development Group – Official Statement10.12.2025 22:06:00 EET | Press release
On 8 September 2025, the Defence, Security and Resilience Bank (DSRB) Development Group convened a high-level meeting in the City of London with representatives from 37 nations, including all G7 members, alongside the European Commission, NATO, European Parliament, Global Banks, and Ratings Agencies to discuss the DSRB. A number of countries have now indicated their intention to begin the formal steps required to bring the DSRB into existence. This phased pattern of engagement is standard in the creation of international financial institutions, which typically begin with a core group of anchor nations and expand as additional members join through charter negotiations and subsequent capital rounds. The DSRB is designed to complement the European Union’s SAFE initiative, offering a broader multilateral platform that brings together NATO and Indo-Pacific nations and mobilises global capital to build the balance-sheet capacity required to finance nations’ defence spending and long-term res
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