ReShape Lifesciences announces EU MDR certification for European, UK portfolio

ReShape Lifesciences (RSLS) 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, 2017/745 and UK Conformity Assessment, UKCA, respectively. “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.