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 [...]
15 04 2025
15 04 2025
19 03 2025
19 03 2025
Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance
Australia: New Procedures for Recalls (PRAC) in Post-Market Surveillance On March 5, 2025, the Australian Therapeutic Goods Administration (TGA) introduced [...]
19 03 2025
19 03 2025
Switzerland: Updates on Safety Measures and IVD Labelling
Switzerland: Updates on Safety Measures and IVD Labelling The regulatory environment in Switzerland is evolving to strengthen both the safety [...]
19 03 2025
19 03 2025
Italy: First NIS2 Fulfilments for Cybersecurity
Italy: First NIS2 Fulfilments for Cybersecurity The Legislative Decree 138/2024 , which was published in the Official Journal on October [...]
18 02 2025
18 02 2025
IVDR Transition: Australia and Switzerland Align With the European Union
IVDR Transition: Australia and Switzerland Align With the European Union In recent years, both Australia and Switzerland have taken significant steps [...]
