The IBV Functional Assessment Laboratory obtains certification under the MDR
The European Medical Device Regulation (EU) 2017/745, commonly referred to as the MDR, has brought about the biggest change in the regulatory framework governing medical devices in the last 25 years. This much more demanding and harmonised legislation has been designed to improve transparency, patient safety and the clinical efficacy of devices.
In this challenging MDR environment, the Instituto de Biomecánica (IBV) has successfully obtained certification for its Functional Assessment Laboratory, thereby guaranteeing that the technologies used in the laboratory meet the highest standards of quality, safety and traceability, and provide healthcare professionals with reliable tools for the functional analysis of patients in clinical, rehabilitation and expert assessment contexts.
To obtain this new certification, the IBV has had to undergo a stringent audit and technical evaluation by Intertek, a notified body designated by the European Commission and empowered to assess, as an independent third party, the extent to which the technologies used by the IBV at its Functional Assessment Laboratory comply with the regulatory and statutory rules of the MDR.
Ignacio Bermejo, Innovation Director at the IBV’s Technologies Division, said that “As far as clinics, hospitals, mutual insurance companies, rehabilitation professionals and public authorities are concerned, this certification provides them with a guarantee that the solutions offered by our Functional Assessment Laboratory comply with all the legal, technical and clinical requirements of the current European regulation”.
IBV recognised as a model of good practices in the development of medical devices
The IBV’s technical excellence, rigour and management system have been recognised by Intertek at the seminar “Medical Devices: from Design to Market Release. What Do I Need to Know?”, organised by the notified body and attended by companies, organisations and public authorities from the healthcare sector.
According to Julia Tomás, the IBV’s Regulatory Compliance Officer, “Obtaining certification under the MDR has been a tough challenge that has required the best efforts of a multidisciplinary team working within the framework of a management system compliant with the international standard ISO 13485. The IBV’s commitment to ensuring that our medical devices offer full guarantees has been the driving force that has enabled us to successfully reach this important milestone”.
Technological solutions for medical practice
This recognition reinforces the IBV’s position as a leading entity in the development of advanced clinical technologies and underscores the added value its solutions bring to real-world medical practice, with applications in occupational medicine, clinical care and biomechanical research.
“This certification endorses the fact that our applied technology in clinical environments complies with the most stringent regulatory criteria in terms of safety, efficacy and quality. In this way, the IBV is continuing to advance in its mission to transform research into useful technology that can be effectively integrated into clinical care processes and improve the quality of life of patients”, says Bermejo in closing.
