VALENCIA, 4 Dec. (EUROPA PRESS) -
The Institute of Biomechanics of Valencia (IBV) works in the different phases of the life cycle of medical devices to help companies adapt to the new European regulations. The center has explained that after the introduction of the new Regulation (EU) 2017/745 on Medical Devices, also known as Medical Device Regulation (MDR), companies run the risk of the products they market being left off the market between 2026 and 2028 if they do not proceed to adapt to the new regulations first.
To address this challenge and respond to the needs of the health products sector, the IBV has promoted the 'Lifemed' project, financed by the Valencian Institute of Business Competitiveness (IVACE) and the European Union. This is an initiative that addresses the complete life cycle of health products in order to generate new knowledge in relation to the design, verification, clinical evaluation, certification and post-marketing monitoring of health products, the institute has detailed. it's a statement.
The Medical Devices Coordination Group (MDR) of the European Commission attributes this fact to the fact that many companies are not prepared and there is poor planning and preparation in the process of adaptation to the MDR, as indicated by the IBV.
Likewise, he has pointed out that the recent extension of the transition periods, carried out in March 2023 by the Parliament and the Council of the Union, is a consequence of this situation and has the objective of avoiding risks of shortages of health products in the EU due to the sector's slower than expected transition.
"We are generating new design and prototyping methodologies for health products, including the study of influential design factors, materials and additive manufacturing technologies. Likewise, we are working on the verification, clinical evaluation and post-marketing monitoring phases of health products, highlighting the development of procedures that allow compliance with the requirements set by the MDR and the competent authorities and a study on the sensorization of health products," explained the director of the Health market area at IBV, Carlos Atienza.
This center works in 'Lifemed' to provide solutions to both current and newly created products, so that manufacturers and the rest of the actors participating in the marketing process can adapt to the new legislation.
"Research focuses on the development of activities aimed at acquiring new knowledge and skills that can be useful to carry out new products, processes or services, or that allow for the considerable improvement of existing ones," added Atienza.
Through these new methodologies, procedures, tools and/or technologies, the IBV encourages companies in the health product sector of the Valencian Community to increase their value proposition with a view to the development of new products and innovative and competitive services, he highlighted. center.
"Among them, it is worth highlighting the creation and training of a neural network that allows for rapid and automated processing of large image databases and that could be used to improve the analysis of the osseointegration capacity of implants that include porous structures versus "the techniques currently used, which have a certain uncertainty when it comes to discerning how far the bone has grown within the pores of the implants. This new methodology could also be applied to the analysis of medical images in different areas," he said. Atienza pointed out.
For this work, the IBV has the collaboration of five leading companies in the health products sector such as IVALMED, Analog Devices, Surgival, Biomet 3i Dental Ibérica and Biovac España.
In this way, the identification of needs is enriched and the value is increased due to the transfer of research results to the business community, to agents in the health products sector and to society in general.