Bioretec Ltd, a pioneer in biodegradable orthopedic implants, expects the European marketing authorization for the RemeOs trauma screw to be delayed from the original estimate of 2022. The company estimates, based on the stage of its own registration process and the latest reports on certifications in the healthcare industry, that obtaining a market authorization will move to 2023. The review process of the CE mark application is ongoing, and the company is still waiting for the feedback from the Notified Body on main sections of the submitted application. The company will disclose further information as soon as more details of the schedule for the market authorization will be available.
Bioretec submitted the CE mark application for the European market authorization at the end of 2021.
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In the European Union, the CE mark applications are handled by Notified Bodies. The workload of the Notified Bodies has recently increased significantly, which has led to elongated handling times for CE certification applications. The ongoing process in the EU to recertify medical devices currently registered under the old Medical Devices Directive (MDD) under the new Medical Devices Regulation (MDR) has resulted to a high number of applications. Recertification approval deadline is latest on May 26, 2024. Aforementioned transition has overwhelmed the Notified Bodies, resulting in a significant increase in timelines also for all new product CE certifications.
“Bioretec does not have control over the current MDR situation and Notified Body review process nor the related schedules. For our part, we will continue to work to complete the market authorization process. The application review process from our Notified Body has already taken longer than previously estimated. According to the industry*, the certification time for new devices is currently in average about 18 months, which is almost a double the time historically needed for certification under the Directives. Due to the reasons mentioned, we consider it to be unlikely that the CE mark would be approved during 2022. We will disclose further information, when more details on the registration process will be available,” says Timo Lehtonen, CEO of Bioretec.