13
Jun 23
The metaverse in healthcare: What are the legal implications?
For some time now, there has been talk of the metaverse as a tool with great potential for increasing opportunities for treatment, research, and training in healthcare.
5
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.
5
Apr 23
Advertising of medical devices and in vitro diagnostic medical devices to the general public: When ministerial authorization is not required
On March 18, two decrees of the Ministry of Health were published in the Official Gazette, both dated January 26, 2023.
5
Apr 23
In the United States, Amazon launched RxPass, a subscription for online purchase of prescription drugs: Could it work in Italy?
A few weeks ago, the company introduced a new subscription service that allows subscribers to purchase more than fifty different prescription medicines for a low fixed months fee. Why this would be prohibited in Italy.
4
Apr 23
Decentralized clinical trials: Recommendation paper for the implementation of uniform procedures in the European Union published
On December 13, the long-waited European Recommendation paper on decentralised elements in clinical trials was finally published, to provide Member States further and more detailed guidance on the implementation of procedures for conducting trials outside of clinical trial centers.
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