EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional provisions of Article 120(3) of the MDR.
21
Mar 22
<!--:it-->Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices<!--:-->
7
Feb 22
New incentives from the Italian Government to promote telemedicine in pharmacies
As was recently demonstrated by the COVID-19 pandemic, the development of telemedicine has been an important tool in the containment of the disease.
7
Feb 22
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
4
Feb 22
IVD devices: Extension of timelines for the application of Regulation (EU) 2017/746
Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices was published on January 25, 2022.
4
Feb 22
Medical Devices Regulation: Note issued by the Ministry of Health to regulate the transition period
On November 12, 2021, the Ministry of Health published a note providing guidance on the provisions of Legislative Decree No. 46/1997 that shall still be considered applicable following the date of the application of Regulation (EU) 2017/745 on medical devices and the issuance of the legislative decrees envisaged by Article 15 of Delegation Law No. 53/2021.
