14
Oct 20
Clinical trials: National Coordination Center of Ethics Committees issues Guidelines for the collection of informed consent
The National Coordination Center of Territorial Ethics Committees for clinical trials on medicines and medical devices (“National Coordination Center”) has drawn up guidelines for the collection of informed consent (“Guidelines”) for participation in clinical trials, pursuant to Legislative Decree No. 211 of June 24, 2003 and Regulation (EU) 536/2014.
12
Oct 20
Telemedicine: Lombardia and Piemonte give the green light to televisits
Since this summer, two additional regions have agreed to allow and recognize televisits at the Regional Health System (“RHS”)’s expenses.
Italian Medicines Agency and medicines shortage: published Q&A for MAHs on notification of shortage and any temporary or permanent interruption in the marketing of medicines
11
Jun 20
Masks, disinfectants, and serological tests: regulatory issues relating to products to be used in phases 2 and 3 of the emergency period
After the lockdown, for correct management of phases 2 and 3, products such as masks and disinfectants become even more essential in containing and preventing the spread of COVID-19.
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.
