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New transparency obligations for medical device companies in Italy

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On 1 January 2021, important transparency obligations provided for in the Code of Ethics of Confindustria Dispositivi Medici (the Italian medical device industry association) (the Code) will become applicable. These obligations require medical device companies to disclose all transfers of value made to healthcare professionals (HCPs), healthcare organizations (HCOs), and other third parties as of 1 January 2020. Starting from this month, therefore, medical device companies that are members of Confindustria Dispositivi Medici should keep track of relevant transfers of value in order to ensure smooth compliance with these new obligations.

In a nutshell, Article 4 of the Code imposes the public disclosure of all direct or indirect transfers of value made to HCPs, HCOs, and other third parties each year, within the first six months of the following year. Such provisions strengthen the disclosure obligations included in the MedTech Code and also apply with respect to “third parties”, defined as those subjects that organize or manage any scientific, logistical or organizational aspects of medical events.

In a nutshell, Article 4 of the Code imposes the public disclosure of all direct or indirect transfers of value made to HCPs, HCOs, and other third parties each year, within the first six months of the following year.

Tags

life sciences, italy, ipt, regulatory

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