Marinomed Biotech AG: First Carragelose Products Receive New Medical Device Regulation (MDR) Certification

Marinomed Biotech AG has achieved a significant milestone with the certification of its first two Carragelose nasal sprays under the EU's new Medical Device Regulation (MDR). Implemented in May 2021, the MDR replaces the previous Medical Device Directive (MDD) and raises the standards for safety, performance, and quality of clinical data for medical devices.

The certification is a crucial step in ensuring the marketing of these products in the EU beyond the transition period ending in 2028. Marinomed's extensive clinical data on Carragelose facilitated the rigorous demands of the MDR transition.

This achievement adds substantial value to Carragelose's portfolio. The company continues to explore strategic options for this business segment, with due diligence processes ongoing but no agreements finalized yet. A decision is expected by the end of the year.

Eva Prieschl-Grassauer, CSO of Marinomed, highlighted the team’s dedication in meeting the new regulatory requirements and expressed confidence in obtaining further certifications for other Carragelose products.