The implementation of the new European Medical Devices Regulation (MDR) has caused a minor revolution in the sector that has required a major effort on the part of companies to adapt to this new framework. The Instituto de Biomecánica (IBV) provides advice on the development, evaluation and certification of medical devices to companies in the HEALTHCARE sector that are committed to the quality and safety of their medical devices as elements of brand identification. One such company is ECOPOSTURAL, a leading company in the field of healthcare furniture, which was granted a manufacturing license by the AEMPS (Spanish Agency for Medicines and Medical Devices) in 2001.
In collaboration with the Galician Health Service (SERGAS) and VECMEDICAL SPAIN S.L., the Instituto de Biomecánica (IBV) has developed an innovative multichannel device for flexible or rigid intrarectal endoscopy and rigid instrument-assisted removal of rectal lesions that cannot be treated using conventional flexible endoscopy techniques. The starting point was a conceptual idea defined by the clinical group, led by Dr. José Noguera, and all the stages of the development were carried out jointly, beginning with the conceptual design and including risk assessment, in vitro functionality tests, redesign, animal experimentation, design for manufacturing and the generation of the necessary documentation for CE marking and to begin clinical trials in humans.
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.