Integrum

"We are happy to have passed the strict validation process to receive an MDR certificate. Based on this accomplishment, we can direct our sole focus on the commercial success of the OPRA^TM Implant System through increased marketing activities and continued clinical evaluation," comments Rickard Brånemark, CEO of Integrum.

To meet the rigorous demands set by the new regulations, Integrum has worked efficiently over the last years to ensure compliance for both the Quality Management System (QMS) and the technical documentation for the OPRA^TM Implant System product assortment. This work included an enhancement of the QMS as well as a thorough review and restructuring of the full technical documentation  to meet the  requirements imposed by MDR. In addition, a review of the clinical evidence and claims of the OPRA^TM Implant System has been made. OPRA^TM Implant System will continue to be offered for three amputation levels in Europe.

Collectively, Integrum has invested approximately SEK 40 million, resulting in improved quality management and technical documentation systems that will play a pivotal role in the continued scale-up of the company.

About MDR
In May 2017, the Regulation on Medical Devices (MDR), formulated by the European Commission (EC), went into effect to replace former legislation concerning quality assessment and risk management in medical devices. The new quality and transparency requirements apply to all medical device companies operating within the European Union (EU). The awarded certificate thereby acknowledges that Integrum fulfills the standards set by the MDR, and provides the company continued freedom to commercialize its medical devices in the EU.