Integrum’s MDR certification is completed for the OPRA[TM] Implant System
Mölndal, Sweden – December 15, 2023 — Integrum (publ) (Nasdaq First North Growth Market: INTEG B) today announces that the company has received its final MDR certification, thus finalizing the review process of the company’s products under the new EU medical device regulatory (MDR) framework. The company’s OPRATM Implant System product portfolio has thereby been granted MDR certification and may be freely distributed within the EU for treatment in individuals living with disabilities because of limb loss.
Integrum received its MDR certification (Notified Body BSI 2797) for the last reviewed articles of its product portfolio on November 23rd, under MDR 2017/745. The MDR certification granted to Integrum allows CE marking of the devices, meaning that the products fulfill the General Safety and Performance Requirements (GSPR) for and use the company’s medical devices falling under classes IIb, IIa, Is, and Ir.
“This is an important step forward for the regulatory robustness of our innovative products. Further, it is an important milestone for the organization, as we finalize many hours of hard work ensuring compliance to the highest possible product standard, which will serve the patients at the end of the chain,” says Annika Fahlén, Quality Assurance and Regulatory Affairs Director, Integrum.
Based on the certification of Integrum’s entire OPRATM Implant System product portfolio, the company is granted freedom of commercial activity in the EU past the start of the enforcement of the framework in 2024. Thus, the company’s current business development activities will not be hampered due to regulatory thresholds.
“We are pleased to have received our finalized MDR certificates, following a thorough process to ensure the highest regulatory standard for our products. This achievement has been made possible thanks to our dedicated team, and it will play an important role as we continue our expansion on the European market," says Rickard Brånemark, CEO of Integrum.
For more information please contact:
Rickard Brånemark, CEO
Phone: +46 (0) 70 846 10 61
E-mail: rickard.branemark@integrum.se
Jörgen Svanström, CFO
Phone: + 46 (0) 70 734 96 60
E-mail: Jorgen.svanstrom@integrum.se
Certified Adviser
Carnegie Investment Bank AB (publ) is the Certified Adviser.
ABOUT INTEGRUM
Integrum AB is a publicly traded company (INTEG B: Nasdaq First North Growth Market) based outside of Gothenburg, Sweden, with a U.S. subsidiary in San Francisco. Since 1990, its OPRA™ Implant System has helped improve the quality of life for hundreds of people who are amputees by directly attaching a prosthesis to the bone and musculoskeletal system, therefore avoiding the need for a socket. Based on osseointegration, the bone-anchored implant system offers a range of benefits, including improved mobility and function, enhanced comfort, reduced pressure, a stable attachment and more. The OPRA™ Implant System was approved by the U.S. Food and Drug Administration (FDA) in 2020 and is the only FDA-approved bone-anchored implant system specifically designed for use in amputees available in the U.S. Today, Integrum continues to perform research and develop custom-made medical device solutions in close collaboration with scientists and clinicians. To learn more, please visit https://integrum.se/.