In transient
With judgment No. 2149 dated 19 January 2022, the Court of Cassation acknowledged the legal responsibility of a manufacturer of medical devices for damages suffered by a affected person resulting from their medical devices breaking throughout surgical procedure.
Key takeaways
- In this regard, the judges of the Supreme Court acknowledged that the “manufacturer is liable, as holder of a position of guarantee, for harmful events causally linked to structural defects of the device placed on the market, unless the user has carried out on the same device transformations of such nature and entity as to be considered a supervening cause sufficient to cause the event.”
- According to the court docket, the supply of this assure obligation is to be present in Legislative Decree No. 46/1997, requiring the manufacturer to supply medical devices “in such a way as their use does not compromise (…) the safety of patients (…), it being understood that any risks must be of an acceptable level (…)”.
- The Court of Cassation additionally identified that, pursuant to Legislative Decree No. 46/1997, the options adopted by the manufacturer for the design and development of the devices should conform to security ideas and get rid of or cut back dangers so far as attainable; the place acceptable, take sufficient safety measures, together with alarms if obligatory, in relation to dangers that can not be eradicated; and inform customers of the residual dangers resulting from any shortcomings of the safety measures adopted.
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Italy: Liability of the manufacturer for damages caused by the break of medical devices & More Latest News Update
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