The Italian Ministry of Health, in a Decree dated 6 July 2022, certified the overrun of the expenditure ceiling for medical devices in Italy, at national and regional level. Companies that have marketed medical devices in Italy at a cost to the national health service (NHS-SSN) during the years 2015, 2016, 2017 and 2018, may soon be required to pay a total amount of approximately 2.08 billion euros. This is unless they manage to effectively challenge (in or out of court) the so-called payback mechanism and the payment demands that will be made by the competent authorities. This is in view of the rules on ‘payback relating to medical devices’ that have been in force for several years but have so far never been applied in practice.

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