Key result
European medical device regulations need stricter pre-market evaluation and monitoring to protect patients from defects.
Why the study?
The current regulation allowing free circulation of medical devices with CE marking in Italy and Europe may expose patients to risks from defective devices lacking adequate pre-market checks.
Highlights the regulatory gaps in European medical device approval and advocates for stricter control policies and patient insurance measures.
Risk of harm from inadequately vetted CE-marked devices warrants clinical caution; leaves open whether stricter premarket oversight is required.
The use of medical devices is in continuous expansion and constitutes a valid aid to ailing people, due to remarkable technological advances. The regulation on their circulation in Italy and Europe are inspired by the principle of free circulation. In fact it is sufficient for a device to have the CE logo for it to be freely commercialized in all of Europe. This way of operating that favours commerce, exposes the sick to the risk of harm from defective devices that have not been suitably checked prior to their commercialization. Having discussed a few episodes characterized by device malfunctioning, the authors observe the need for a more careful “control” policy for devices, adequate care on the part of doctors who use such tools, and of suitable insurance measures for the patient in the event of harm.
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Vacchiano et al. (2015) conducted a review in Medical device safety and regulation. Medical devices was evaluated. The current European regulatory framework for medical devices requires more stringent pre-market evaluation, careful monitoring, and maintenance policies to protect patients from defective devices.
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