Home Europe Italy

Italy

Italy: Custom-made, adaptable and patient-matched medical devices: clarifications from the Medical Device Coordination Group

0
With the document "MDCG 2021-3 Questions and Answers on Custom-Made Devices" published on 15 March 2021, the Medical Device Coordination Group (MDCG) provided clarifications on the regulation of custom-made medical devices falling within the scope of Regulation (EU) 2017/745. The purpose of this document is to outline the differences among three different categories of seemingly similar medical devices: custom-made, adaptable and so-called patient-matched devices.

Italy: Covid-19 Emergency Update: New Protocols on safety measures in the workplace and the...

0
The Italian government and the National Trade Unions signed on 6 April 2021 the new Protocol on Health and Safety measures in the workplace (document in Italian here), with the aim of containing the spread of the COVID-19 virus and which updates the previous protocol signed on 14 March 2020 and updated on 24 April 2020 (see our newsletter on the protocol of 14 March here and the one on the protocol of 24 April here).

Italy: COVID-19 – Mandatory vaccination for healthcare professionals

0
On 1 April 2021, Decree-Law No. 4/20201 has been published in the Italian Official Gazette whose Section 4 introduces the compulsory vaccination against COVID-19 for healthcare professionals and operators and provides a detailed procedure for its operation and sanctions in case of non-compliance.

Italy: New EU export authorization regime for COVID-19 vaccines and active substances

0
With EU Implementing Regulation 2021/442 of 11 March 2021, the European Commission introduced a new export authorization regime for COVID-19 vaccines applicable until 30 June 2021 which replaces the one initially established with EU Implementing Regulation 2021/111 of 29 January 2021. In particular, the new Implementing Regulation provides that the export outside the EU of vaccines and active substances classified with the identification codes listed therein is subject to prior authorization.

Italy: Energy & Sustainability Newsletter – April 2021

0
In brief Italy Energy & Sustainability Newsletter for the month of April 2021.ContentsThe Italian Ministry of Ecological Transition has been established The changes in...

Global: Crypto around the World

0
Since the ICO boom in 2017, governments around the world began settling on different approaches to regulating the crypto industry. Many legislatures and regulators...

Italian Medicines Agency – Simplified procedure for parallel imports of medicines

0
In brief With Directorial Determination No. 357/2021, the Italian Medicines Agency (AIFA) adopted a new simplified procedure for negotiating the price and reimbursement of medicines...

Italy: A new Decree with measures aimed at supporting companies and employees during the...

0
On 23 March 2021, a new Decree no. 41/2021 named Sostegni (you can read the Italian version of the decree here), came into force, providing for new measures to support business activities impacted by the COVID-19 emergency.

International: G7 Statement Commits to Continued Russia Sanctions over Crimea

0
In an 18 March 2021 statement released by the German Foreign Ministry, the Group of Seven (G7) nations have announced that they remain fully...

Italy: Council of State: Contracting authorities can refuse to award public tenders for unsuitable...

0
With Judgment No. 1455 dated 17 February 2021 the Council of State upheld the decision of a contracting authority not to award a public tender for the supply of antiseptics and disinfectants where the only valid offer was found to have a value higher than that identified through a comparative survey of the prices of goods in the healthcare sector.
Send this to a friend