Masotti Cassella

Quello della responsabilità medica resta uno dei settori più appetibili nell’ambito legale. Un ambito che però presenta ancora luci e ombre e che richiede sempre più una maggiore specializzazione. C’è da dire che dall’introduzione della legge 24/2017 ci sono stati sicuramente degli effetti positivi, come la riduzione dei costi della cosiddetta «medicina difensiva». A rivelarlo […]

Main features of the regime 1. Foreword On 31 May 2022, the Italian Parliament approved Law 62/2022, also referred to as the Sunshine Act to regulate dealings “between manufacturing companies, subjects operating in the health sector, and health organisations”. The Act (published in the Official Gazette no. 135 of 11 June 2022) came into force […]

Italy continues with the harmonisation of its system with the MDR and IVDR. Previous measures (commencing with Legislative Decrees 137/2022 and 138/2022) established the categories of devices for which advertising is prohibited: i.e. (i) custom-made MDs; (ii) MDs requiring the mandatory assistance of a doctor or other health professional for use; (iii) MDs requiring a […]

On September 13 2022, Legislative Decrees on medical devices (137/2022) and in vitro diagnostics (138/2022) were published in Italy’s Official Gazette. These measures harmonize Italian law with the new EU Regulations 745/2017 and 746/2017 (“Regulations”) – amending and repealing (with specific timelines) the previous decrees – and introduce a new legislative framework consistent with the […]

I DL n.17/2022 (“Decreto Energia”) e DL 21/2022 (“Decreto Ucraina”) hanno introdotto alcune agevolazioni fiscali per il contenimento dei costi sostenuti per l’acquisto dell’energia elettrica e del gas naturale e per contrastare gli effetti economici e umanitari della crisi ucraina. Il DL n.17/2022 (Decreto Energia), prevede le seguenti agevolazioni fiscali: – all’articolo 4, un credito […]

Introduction The pandemic has made some critical aspects of a structural nature even more evident in the health sector, which in the future could be aggravated by the increased demand for care resulting from the ongoing demographic, epidemiological and social trends; in particular: (i)   significant territorial disparities in the provision of services; (ii)  inadequate synchronisation […]

Prior to the innovations introduced by Article 7 of the Medical Device Directive 2017/745 (the “MDR”) there was little uniformity of approach or guidance on the issue of advertising and what statements could be made in relation to medical devices (“Advertising). There was no reference to Advertising in the Medical Device Directive 93/42/EEC of 14 […]