Related Experiment Video
Updated: Feb 5, 2026

Implementation of Portable Emissions Measurement Systems PEMS for the Real-driving Emissions RDE Regulation in Europe
Published on: December 4, 2016
On a defective Mitraclip® system: Considerations on the medical device regulation in Europe
Arturo Giordano1, Angela Silvestre, Maria Pieri
1Invasive Cardiology Unit, Pineta Grande Hospital. arturogiordano@tin.it.
Abstract:
The use of medical devices is constantly growing and constitutes a valid aid to ailing people because of remarkable technological advances. The regulations on their circulation in Italy and Europe are inspired by the principle of free circulation: it is sufficient for a device to have the CE logo for it to be freely commercialized in all European countries. These regulations that favors commerce also expose the sick to the risk of harm from defective devices that have not been suitably checked prior to commercial release. This paper reports a case of a defective MitraClip® Delivery System, discusses other episodes of similar device malfunctioning, and analyzes the European legislation on medical devices. In the author's opinion, a careful "control" policy for devices, an adequate care in device manufacturing, an appropriate evaluation of pre- and post-marketing and suitable measures for the patient's safety are needed.
Related Concept Videos
Design Consideration
The factor of safety is another key...
Lumber Defects
Shakes are minor fractures that run along or across the wood's annual rings, while wane is...
Inhaled Medications
Tensile Strength Considerations of Concrete
The dimensions and shape of a concrete specimen...
Transmission Line Design Considerations
Epigenetic Regulation

