Medical Advertising in Italy: The New Guidelines
Translated with AI On July 21, 2025, the Italian Ministry of Health published new Guidelines on medical advertising for Medical Devices, [...]
27 08 2025
27 08 2025
10 07 2025
10 07 2025
What is the UDI for Medical Devices and IVDs, and what is it for?
Unique Device Identification (UDI) is a global identification system designed to enhance the traceability and security of Medical Devices and [...]
10 07 2025
10 07 2025
What is the correct format of the expiry date to be reported in the UDI vector?
In the UDI vector (the GS1-128 or DataMatrix barcode on the label of the medical device), the expiry date must be [...]
20 05 2025
20 05 2025
News on South Korea’s K-GMP Regulations for Medical Devices and IVDs
With the notice MFDS NO. 2025-22 dated April 7, 2025 the Ministry of Food Safety and Drugs (MFDS) of South Korea has [...]
15 04 2025
15 04 2025
Update of MDCG Guidance 2020-16 on the Classification of IVDs in the EU
On March 18, 2025, the Commission's Directorate-General for Health and Food Safety published Revision 4 of MDCG Guidance 2020-16, dedicated [...]
18 02 2025
18 02 2025
Vigilance on Medical Devices: Update of MDCG Guidelines 2023-3 Rev.2
Vigilance on Medical Devices: Update of MDCG Guidelines 2023-3 Rev.2 Vigilance on Medical Devices is a key activity to ensure patient [...]
