Endo Tools Therapeutics is pleased to announce the obtention of CE marking for endomina® and TAPES under European Union Medical Device Regulation (EU MDR) through completion of the certification process.

This represents another significant regulatory achievement for Endo Tools Therapeutics and underscores its dedication to delivering high-quality products to its customers. The certification process under the Medical Device Regulation (MDR) sets a higher bar compared to the previous Medical Device Directive (MDD) certification. MDR imposes stricter criteria for clinical assessment, post-market oversight, and incident reporting, necessitating greater investment in resources and data.

Endo Tools Therapeutics takes pride in joining the ranks of the limited number of companies that have navigated the MDR process smoothly within the set transition period. This achievement ensures the company’s ability to serve European markets for years to come.