EU: New Harmonised Standards for Medical Devices
The European Commission has recently updated the list of harmonised standards to support compliance with the MDR(EU) Regulations 2017/745 (EU) and [...]
20 05 2025
20 05 2025
19 05 2025
19 05 2025
Medical Devices Post-Market Surveillance
This white paper provides an overview of the basic concepts and requirements of the Post-Market Surveillance System (PMS) in the [...]
23 04 2025
23 04 2025
IVDR Deadlines: All Key Dates for Legacy and Non-Legacy IVDs
The in vitro diagnostic medical device (IVD) industry is going through a challenging transition phase, marked by the IVDR Regulation [...]
15 04 2025
15 04 2025
European Health Data Space Regulation (EHDS): New Obligations for Medical Device Manufacturers
With the adoption of Regulation (EU) 2025/327 the European Union has officially established the European Health Data Space (EHDS), introducing important [...]
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 [...]
15 04 2025
15 04 2025
Terminology for Adverse Events in Medical Devices: IMDRF Update, March 2025
The IMDRF (International Medical Device Regulators Forum), an international cooperation body promoting the harmonisation of medical device regulation, published on March [...]
19 03 2025
19 03 2025
EUDAMED: Deadlines and Obligations for Economic Operators
EUDAMED is the database developed by the European Commission to centralise and make easily accessible information on Medical Devices and In [...]
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 [...]
