IRVINE, Calif., June 03, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that its Quality Management System (QMS) and entire commercial portfolio of medical devices sold in Europe and in the United Kingdom (UK) have been certified under the European Union (EU) Medical Device Regulation (MDR) (EU) 2017/745 and UK Conformity Assessment (UKCA), respectively.
The EU MDR, which replaced the Medical Device Directive (MDD) in May 2021, sets significantly more stringent requirements for clinical evaluation, post-market surveillance, and device traceability. Its goal is to improve patient safety, transparency, and product quality across all 30 countries within the European Economic Area (EEA). The UKCA has replaced the CE mark for certain goods placed on the market in Great Britain (England, Scotland, and Wales). It ensures that products meet the UK's regulatory requirements for safety, health, and environmental protection.
"Achieving MDR and UKCA certification well in advance of the December 31, 2027 regulatory deadline is a significant milestone that firmly establishes ReShape Lifesciences among a select group of medical device manufacturers capable of meeting the European Union's rigorous new standards," stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences. "We have invested in the infrastructure necessary not only to comply with the MDR's demanding framework, but also to support ongoing innovation and maintain seamless access to all 30 countries within the EEA. We are proud to join the relatively small number of companies that have successfully navigated this rigorous process. As a result, ReShape Lifesciences is uniquely positioned to expand its product pipeline, knowing that the systems and infrastructure supporting its QMS align with the EU's and UK's highest standards. This certification not only secures our continued presence in the European market, but also reinforces our mission to deliver safe, effective, and innovative solutions to patients living with obesity worldwide."
"Securing MDR and UKCA certification for our products and our QMS is a clear validation of our regulatory and quality systems," said Dov Gal, Vice President of Regulatory, Quality, and Clinical Affairs at ReShape Lifesciences. "As of late 2023 and early 2024, many legacy devices that were previously approved under the older MDD framework were still awaiting MDR and UKCA certification. With only a small percentage of applications resulting in approved certificates at that time, the risk of device shortages across the EU market became increasingly apparent. ReShape's early compliance ensures uninterrupted availability of our devices in Europe and demonstrates our commitment to meeting the highest standards of safety and performance under the new regulatory landscape."
About ReShape Lifesciences®
ReShape Lifesciences® is America's premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® System provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The investigational Diabetes Bloc-Stim Neuromodulation (DBSN) system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit www.reshapelifesciences.com.
Forward-Looking Safe Harbor Statement
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as "expect," "plan," "anticipate," "could," "may," "intend," "will," "continue," "future," other words of similar meaning and the use of future dates. Forward-looking statements in this press release include statements about the company's expected commercial launch of the Lap-Band® 2.0 FLEX in Canada and related expected sales growth. These and additional risks and uncertainties are described more fully in the company's filings with the Securities and Exchange Commission, including those factors identified as "risk factors" in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.
CONTACTS
ReShape Lifesciences Investor Contact:
Paul F. Hickey
President and Chief Executive Officer
949-276-7223
ir@ReShapeLifesci.com
Investor Relations Contact:
Rx Communications Group
Michael Miller
(917)-633-6086
mmiller@rxir.com
