According to the new European Regulation 2017/745 (MDR), since its recent effective coming into force, some medical devices have been reclassified based on their specific risk: the regulation, which focuses on the essence of the device, emphasizes furthermore the fact that the device must be evaluated on the basis of its actual use according to the famous parameters of "therapy", "diagnosis" and "cure" to decide whether or not to classify it as a medical device.
In this regard, we remind you of the reclassification of our medical suction units (BSU) in class IIA, while their wall bracket, which remains tested according to UNI EN 1789, IEC 60601-1 and ISO 10079-1 standards, is no longer classified as a medical device. The power supply of the BSU units, also always evaluated to meet high quality standards and checked for risks related to patient safety, is not classified as a medical device either. In addition, the jar for the collection of secretions, essential for the BSU devices to function properly, is also sold individually as a spare part of the suction unit and it is not classified by itself as a medical device.
We are updating all the documentation related to the products mentioned above, but it seemed important to reiterate some aspects on the classification of the devices, which do not in any way affect the level of attention and quality of the production and/or testing processes but simply adapt to what foreseen by the MDR regarding the risk of medical devices.
As always, we remain available for any further information.