ReShape Lifesciences® Announces EU MDR Certification for Entire European and United Kingdom Product Portfolio

Rhea-AI Summary

ReShape Lifesciences (RSLS) has achieved EU Medical Device Regulation (MDR) certification and UK Conformity Assessment (UKCA) certification for its entire product portfolio and Quality Management System ahead of the December 31, 2027 deadline. This certification ensures compliance with stringent European and UK regulatory requirements for medical devices, covering clinical evaluation, post-market surveillance, and device traceability across all 30 European Economic Area countries. The achievement positions ReShape among a select group of medical device manufacturers meeting these new standards, ensuring uninterrupted product availability in European markets and supporting future innovation in obesity treatment solutions.

Positive

• Early certification achieved well ahead of December 2027 deadline, ensuring uninterrupted market access
• Positions company among select few medical device manufacturers meeting new EU standards
• Certification covers entire commercial portfolio for both EU and UK markets
• Enables continued product pipeline expansion with aligned quality systems

Negative

• None.

Insights

Regulatory Affairs Specialist

ReShape securing early EU MDR certification removes significant market access risk and potentially creates competitive advantage in European markets.

The certification of ReShape Lifesciences' Quality Management System and product portfolio under the EU Medical Device Regulation (MDR) and UK Conformity Assessment (UKCA) represents a significant regulatory achievement. By securing these certifications well ahead of the December 2027 deadline, ReShape has effectively mitigated a substantial business risk that many medical device companies still face.

The EU MDR, which replaced the less stringent Medical Device Directive in 2021, has created a challenging regulatory environment with only a small percentage of applications successfully receiving certification. The regulation imposes considerably more demanding requirements for clinical evaluation, post-market surveillance, and device traceability across all 30 European Economic Area countries.

This early certification provides ReShape with several strategic advantages:

• Guaranteed uninterrupted market access in Europe and the UK
• Competitive differentiation from manufacturers still struggling with certification
• Reduced regulatory uncertainty for investors and partners
• A validated quality management infrastructure that supports future innovation

The company's statement that they join a "select group of medical device manufacturers" capable of meeting these standards appears credible given the widely reported certification bottlenecks across the industry. Many legacy devices remain in regulatory limbo, creating potential market disruptions and product shortages.

This achievement demonstrates ReShape's regulatory maturity and commitment to maintaining compliance with evolving global standards. While this certification primarily secures existing market access rather than opening new revenue streams, the prevention of potential European market exclusion represents a significant risk mitigation for the company's international commercial strategy.

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

FAQ

What certifications did ReShape Lifesciences (RSLS) receive for its European operations?

ReShape Lifesciences received EU Medical Device Regulation (MDR) certification and UK Conformity Assessment (UKCA) certification for its entire product portfolio and Quality Management System.

When is the deadline for EU MDR compliance and how early did RSLS achieve it?

The regulatory deadline is December 31, 2027, and RSLS achieved certification well in advance of this date.

What markets does the EU MDR certification cover for ReShape Lifesciences?

The EU MDR certification covers all 30 countries within the European Economic Area (EEA), while the UKCA covers Great Britain (England, Scotland, and Wales).

What are the benefits of EU MDR certification for ReShape Lifesciences?

The certification ensures uninterrupted product availability in European markets, supports future innovation, and validates the company's regulatory and quality systems while meeting stringent safety and performance standards.

How many medical device companies have achieved EU MDR certification?

According to the press release, only a small percentage of applications have resulted in approved certificates, making ReShape Lifesciences part of a select group of manufacturers meeting these standards.