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.
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.
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.
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
Transparency and responsibility regarding medical-scientific information on the web
On September 28, two international pharmaceutical industry associations, the IFPMA and the EFPIA, published a Joint Note for Guidance on social media and digital channels to guide the work of pharmaceutical companies that use the web to provide doctors and patients with information about their products and the illnesses they are intended to treat.