9
Jun 20
Italian Competition Authority approves two emergency cooperation projects: one for joint distribution of surgical masks and one common moratorium scheme on consumer lending
On May 27, 2020, for the first time the Italian Competition Authority (“AGCM”) applied its communication on cooperation agreements in the context of the COVID-19 emergency (“Italian Communication”), applicable since April 24, 2020.
8
Jun 20
Health Claims on Botanicals: according to the Council of State, unauthorized claims may be used if scientifically proven
With judgment No. 2371 of April 10, 2020, the Council of State (or the “Court”) provided significant clarification regarding health claims that can be used with respect to a category of food supplements made of plant materials and herbal preparations (“Botanicals”).
29
May 20
Italy: Garante's crackdown on patient health data protection
The Italian data protection authority (‘Garante’) announced, on 6 March 2020, that it had reached an agreement with Consip S.p.a. regarding modifications rules regarding calls for tenders concerning the purchase of medical equipment and devices, aimed at making the same compliant with data protection legislation.
29
May 20
COVID-19 emergency and processing of health data for scientific research purposes
The health emergency due to the spread of COVID-19 has made the need to correctly manage the processing of health data for scientific research purposes even more topical.
Medical Devices Regulation: Regulation 2020/561 has been published in the Official Journal of the European Union postponing the date of application of MDR by one year to 26 May 2021
9
Apr 20
Medical Devices Regulation: EU Commission proposes a one year postponement of the application date
On 3 April 2020, to prioritize the fight against the Covid-19 pandemic crisis, the European Commission adopted a proposal to (i) postpone the date of application of Regulation (EU) 2017/745 on medical devices (“MD Regulation”) (scheduled for 26 May 2020) by one year and (ii) deviate from the normal conformity assessment procedures of medical devices in cases of need and emergency.