The European market authorization process for Bioretec Ltd.'s RemeOs? trauma screw, a pioneer in biodegradable orthopedic implants, still continues by the Notified body (Dekra). The company estimates that the CE mark for the trauma screw will not be obtained during the end of 2023, as previously expected.

Bioretec now estimates that the European market authorization for the product will be obtained during the first quarter of 2024. The reason for the schedule change is not related to the company but to the Notified Body?s prolonged response times and insufficient resourcing to support the company's CE mark application process, which has resulted in a very slow handling of the application process. Bioretec submitted the CE mark application for the European market authorization at the end of 2021.

The slow progress of handling of the company?s CE mark application has continued at the Notified Body, as the increase in the number of applications caused by the change in the European Medical Device Regulation (MDR) of medical devices has kept the Notified Institutions still congested and has led in prolonged certification processes.