Bioretec updates its estimate of the timing for approval of the CE mark for the RemeOs™ trauma screw
Bioretec Ltd Inside information 4 November 2022 at 6:15 p.m. EET
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.
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.
*More detailed information on CE certification status on healthcare industry in Europe is available on MedTech Europe Survey report. https://www.medtecheurope.org/wp-content/uploads/2022/07/medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation.pdf
Further enquiries
Timo Lehtonen, CEO, tel. +358 50 433 8493
Johanna Salko, CFO, tel. +358 40 754 8172
Certified Adviser: Nordic Certified Adviser AB, tel. +46 70 551 67 29
Bioretec in brief
Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioresorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries.
Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. The first RemeOs™ product market authorizations are expected in U.S. during April 2023 and in Europe during 2023. Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical possibilities.
Better healing – Better life. www.bioretec.com
