The period of transition for Class I medical devices to the new regulatory framework established by EU Regulation 2017/745 on medical devices, also known as MDR, will come to an end on 25 May 2021. As of this date, if they wish to continue marketing these products, all manufacturers and their respective products must adapt to the MDR.
This article will address the main changes introduced by the new regulatory framework and will provide the keys to a successful transition for class I medical device manufacturers.
The Instituto de Biomecánica (IBV) is setting up an innovative service for the biomechanical functional assessment and monitoring of daily activity that will make it possible to know the progress of patients with knee prostheses. This service will provide the manufacturers of medical devices with objective and relevant clinical information on the functioning of their products, which will strengthen their post-market surveillance systems. In addition, this service will benefit hospitals by allowing them to objectively measure the effectiveness of their procedures and rehabilitation treatments, thus helping them improve the resource management.
Alzheimer's disease affects 14 million people in the world. To facilitate the effectiveness of new treatments, early detection of the disease is vital. The Valencian company Oncovision, with the collaboration of the I3M and the Institute of Biomechanics (IBV), has developed a new diagnostic imaging equipment based on PET technology that will make it possible to detect the disease in very early stages and with a high degree of accuracy.
The company Mercé Electromedicina, S.L., with the collaboration of the Instituto de Biomecánica (IBV) has developed a system capable of modifying the lineal flow of a conventional heart pump, and of converting it into a pulsatile flow. Among the most outstanding features of this system, known as PULSAMED, are its low cost and the fact that it makes it possible to choose pulse-related energy independently from the blood flow you choose. The maximum values reached by pulse-related energy quadruple those found in scientific literature.