Implications of the new MDR (EU 2017/745) for Class I medical devices
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.
Artificial grass in municipal sports facilities. From the tender to its maintenance
Artificial grass pitches have evolved significantly since the 1960s. The improvement in materials and in their installation have increased their performance to a level similar to that of natural grass pitches, and such aspects as their maintenance and the intensive use of the facilities have also been improved. In order to reduce problems in new installations or in the renovation of existing ones, the execution of the different phases is crucial, ranging from the correct drafting of the tender documents to the execution and supervision of the work itself, or the moment of its acceptance. All this, without forgetting about the need to carry out maintenance work that allows us to extend the life of the pitch in the best possible conditions. The Instituto de Biomecánica (IBV) makes its knowledge and experience in this field available to the sector, as a technological partner.
Making autonomous vehicle decisions more human. Project SUaaVE
The acceptability of connected and autonomous vehicles is a complex process involving several factors including individual, social, cognitive and perceptive factors, among others. The SUaaVE project has built a model for evaluating emotions in order to integrate the user's emotions and sensations into the behavior of an autonomous vehicle. The basis of this model is a set of rules that determine the emotion that a person is feeling, based on environmental data and data from the individual themself.
Implicaciones en los productos sanitarios de Clase I por el nuevo MDR (EU 2017/745)
El próximo 25 de mayo de 2021 finaliza el periodo de transición establecido para productos sanitarios de clase I al nuevo marco regulatorio establecido por el Reglamento (UE) 2017/745 sobre producto sanitario, también conocido como MDR. A partir de esta fecha, todos los fabricantes y sus respectivos productos deberán estar adaptados al MDR para poder seguir comercializando dichos productos.
En el presente artículo abordaremos los cambios principales introducidos por el nuevo marco regulatorio, facilitando las claves para una transición exitosa para los fabricantes de producto sanitario de clase I.