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The new Medical Devices Regulation (MDR) will enter into force on 25 May 2017
As anticipated in the previous article about the topics emerged in the 56th European coordination round table for Notified Bodied regarding MDD held in Brussels last April, in which ECM took part as Notified Body with our Engineer Vanessa Biavati, the new regulation introduces important changes in Medical Devices World, either for manufacturer/distributors and Notified Bodies. If the producers have to adapt their devices to new standards imposed by the new regulation, on the other hand Notified Bodies have to build their resources in order to be ready for the new MDR, considering that the range of products which requires the intervention of a Notified Body is going to increase.
One of the goal of new regulation is to increase the quality and safety of the products, through rigid requirements in matter of technical documentation, clinical evaluation and post-marketing surveillance, allowing a better tracking in the whole production line, for an increased transparency. Moreover, with the arrivals of new technologies, the new MDR has intended to provide a concrete answer to the need of amplify and specify the Medical Devices codification system, related to their application field and intended use.
From now, is going to start a long adaptation process for Medical Device companies. As Notified Body and Accredited Testing Laboratory, Ente Certificazione Macchine is already working to enhance its own services and expertise fields in order to give the most appropriate answer to those Medical devices companies which need to be guided during the actual normative transition.
Visit our website for medical devices www.entecerma-usa.it
Ente Certificazione Macchine
Via Cà Bella, 243
Location Castello di Serravalle (Bo) Italy
P. +39 051 6705141
F. +39 051 6705156