Bioretec estimates that approval under the CE Mark for the biodegradable RemeOs trauma screw will move to 1Q24.
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 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.
“Regulatory approvals are an integral and important part of a commercialization process in our industry. The approval processes and schedules of product registrations are always subject to uncertainty, and the company has limited opportunities to influence those. For our part, we will continue to work to obtain a market authorization and start commercialization in Europe,” says Timo Lehtonen, CEO of Bioretec.
Bioretec estimates that approval under the CE Mark for the biodegradable RemeOs trauma screw will move to 1Q24.
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...
Bioretec estimates that approval under the CE Mark for the biodegradable RemeOs trauma screw will move to 1Q24.
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 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.
“Regulatory approvals are an integral and important part of a commercialization process in our industry. The approval processes and schedules of product registrations are always subject to uncertainty, and the company has limited opportunities to influence those. For our part, we will continue to work to obtain a market authorization and start commercialization in Europe,” says Timo Lehtonen, CEO of Bioretec.
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