ReShape Lifesciences Secures EU, UK Medical Device Certification

ReShape Lifesciences has achieved a major regulatory milestone by obtaining Quality Management System (QMS) certification and approval for its entire commercial medical device portfolio under the European Union Medical Device Regulation (MDR) and the UK Conformity Assessment (UKCA). This certification, secured well ahead of the December 31, 2027 deadline, positions the company among a select group of manufacturers compliant with the EU's more stringent standards aimed at enhancing patient safety, clinical evaluation, and product traceability. The company’s CEO, Paul F. Hickey, emphasized that this accomplishment validates their investment in infrastructure to maintain seamless access across the European Economic Area and the UK, supporting ongoing innovation and expansion of their product pipeline. Despite the positive regulatory developments, analysts currently assign a “Hold” rating to the stock, with some forecasts indicating significant downside from recent prices and expected non-profitability for the year. ReShape Lifesciences’ shares reacted positively to the news, jumping over 33% on heavy trading volume. The certifications secure the company’s ability to continue selling in Europe and the UK under the new regulatory environment, which replaced previous directives with more rigorous requirements since May 2021.