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
MediaCo Appoints Brian Fisher as President21.7.2026 23:15:00 EEST | Press release
MediaCo Holding Inc. (Nasdaq: MDIA) today announced executive leadership appointments that align the Company's leadership structure to support its long-term growth strategy. Effective immediately, Brian Fisher has been appointed President of MediaCo. Albert Rodriguez will continue to serve as Chief Executive Officer, focusing on the Company's long-term strategy, growth initiatives and shareholder value, while Fisher assumes responsibility for leading the Company's day-to-day operations and execution. The Company also announced that Roberto Castro has been appointed Interim Chief Financial Officer and Interim Treasurer, overseeing the Finance organization while a search is conducted for a permanent Chief Financial Officer. "MediaCo has built tremendous momentum, and these leadership appointments position us well for our next phase of growth," said Albert Rodriguez, Chief Executive Officer of MediaCo. "Brian is the right leader to serve as President, and Roberto's financial expertise wil
Footprint Expands Into PE-Free Cups, Bringing a Proven, Recyclable and Home-Compostable Alternative to Plastic-Lined Paper Cups Into Production21.7.2026 19:00:00 EEST | Press release
Footprint, a materials science and technology company focused on eliminating single-use plastics, today announced it has acquired a recyclable, home-compostable, polyethylene (PE)-free hot and cold cup platform from Transcend Packaging, along with next-generation paper lid and straw solutions. Transcend Packaging is a European company focused on innovation in sustainable packaging solutions. Together, the cup, lid, and straw expand Footprint’s portfolio with a proven solution for the global cup market. Footprint will begin scaling its new PE-free solution through its Poland facility as the company expands across Europe, with North America to follow. As operations ramp in Poland, Footprint will work with Transcend through a manufacturing partnership to support customer continuity across Europe and meet growing demand for practical alternatives to plastic-lined cups. Transcend will manufacture product from its Wales facility for Footprint customers, while continuing to serve customers in
Spectro Cloud Launches PaletteAI Inference Launchpad to Reduce Enterprise Token Costs by up to 70%21.7.2026 17:00:00 EEST | Press release
Spectro Cloud, a leading provider of AI infrastructure management software, today launched PaletteAI Inference Launchpad, a turnkey, locally managed solution designed to help enterprises reduce token costs by as much as 70% and run AI inference closer to their data, applications and users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721597271/en/ The company also announced expanded PaletteAI support for AMD-powered AI infrastructure, including AMD GPUs, AMD GPU Operator, ROCm™ runtime, and the AMD enterprise AI reference stack — including AMD-optimized models from the AMD Inference Microservices (AIMs) catalog. Together, the announcements expand PaletteAI as one platform for production AI infrastructure across heterogeneous environments — giving enterprises, neoclouds and sovereign cloud providers a more flexible path to run governed AI infrastructure across NVIDIA and AMD silicon. AI infrastructure is entering the tok
RecVue Launches First AI Native Agentic Revenue Operating System21.7.2026 16:03:00 EEST | Press release
RecVue, the leader in billing and revenue management solutions, today announced the evolution of RecVue RevOS into the industry's first Agentic Revenue Operating System. In an architectural shift, the now-native agentic revenue management platform moves revenue operations beyond AI-assisted workflows to fully governed, autonomous execution with more than 50 purpose-built agents that work across contracts, invoices and payment data to predict risk, surface anomalies and escalate exceptions throughout the quote-to-cash lifecycle. Enterprise revenue operations have long suffered from a structural gap between billing systems that generate invoices and ERP systems that record transactions. Finance teams face tedious, manual reconciliation month after month, often resulting in delayed cash, billing errors that generate disputes, revenue leakage from ungoverned contract changes and close cycles that consume weeks. “Enterprise RevOps has always demanded both speed and precision, but traditiona
Yubico Extends Passkeys Beyond Trusted Authentication to Verified Authorization with Launch of YubiKey 5.821.7.2026 16:00:00 EEST | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), the pioneer of phishing-resistant authentication and creator of the original passkey, the YubiKey, today announced the general availability of its YubiKey 5.8 – marking an expansion of the role of the passkey from secure authentication to include verifiable, hardware-backed authorization. The new firmware delivers a foundation for secure enterprise workflows across identity wallets, document signing, and AI-driven approvals, while also providing developers with the critical capabilities needed to test, design and deploy these next-generation security features early. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721286409/en/ As generative and agentic AI mature to drive rapid, automated cyberattacks, traditional multi-factor authentication (MFA) is failing to keep pace. Security leaders now face a challenge globally: securing not just who logs into a system, but exactly what actions a us
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