Core Insights - ReShape Lifesciences has achieved certification for its Quality Management System (QMS) and medical devices under the EU Medical Device Regulation (MDR) and UK Conformity Assessment (UKCA), ahead of the December 31, 2027 deadline [1][3] - The EU MDR, effective since May 2021, imposes stricter requirements for clinical evaluation, post-market surveillance, and device traceability to enhance patient safety and product quality across the European Economic Area [2] - The certification positions ReShape Lifesciences among a select group of manufacturers compliant with the EU's rigorous standards, enabling the company to expand its product pipeline and maintain market access in Europe [3] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band System and investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system [4] - The company’s offerings include non-surgical options like the Obalon balloon technology, designed for long-lasting weight loss [4]
ReShape Lifesciences® Announces EU MDR Certification for Entire European and United Kingdom Product Portfolio