Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, implementing Lgs. D. 137/2022, were published on 13 and 14 June.
Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, implementing Lgs. D. 137/2022, were published on 13 and 14 June.
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Apr 23
Regulation (EU) 2023/607 extending CE certificates for medical devices and in vitro devices came into force
Regulation (EU) 2023/607 extended the duration of CE certificates for legacy devices and the relevant period during which such devices can be placed on the market or put into service, previously scheduled to expire on May 26, 2024.
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical devices entered into force following publication on EU's Official Journal
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Oct 22
Payback mechanism for medical devices in light of the Aiuti-bis Decree
On September 22, Law No. 142/2022 converting Decree-Law No. 115 of August 9, 2022 (the “Aiuti-bis Decree”) was published.
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published in the Official Gazette
6
Jul 22
Clinical trial contracts: What the new NCCEC models provide
On May 31 of this year, the National Center for the Coordination of Ethics Committees updated its model drug and medical device trial contracts. They are the benchmark for regulating the relationships between sponsors, CROs, and research centers involved in clinical trials.
