The MDCG Group (Medical Device Coordination Group) just released a revised version of MDCG 2023-3. This guidance document provides answers to different questions concerning vigilance…
MDCG: Ethylene Oxide in medical devices and Borderline Classification
In October 2024, the MDCG published two documents: one on the regulatory status of ethylene oxide (EtO) used for the sterilisation of medical devices, and…
Notification for interruptions or discontinuations in the supply of medical devices
In its recent Regulation (EU) 2024/1860, the European Commission introduced amendments to the Medical Devices Regulations (MDR and IVDR). One of the main novelties of…
European Parliament votes in favour of MDR & IVDR resolution
Today, 23 October 2024, the European Parliament votes in favour of a resolution to update the Medical Devices Regulations within 180 days. The motion passed…
Updated MDCG 2021-25 on MDR legacy requirements
MDCG just updated its guidance document on the application of MDR requirements to legacy devices and to devices placed on the market prior to 26…
Harmonised standards for aseptic processing and clinical performance studies
On 9 October 2024, the European Commission published new harmonised standards in support of the EU medical devices Regulations (MDR and IVDR). These new standards…
MDR: 50 Notified Bodies on NANDO!
The NANDO database now includes the NEOEMKI LLC, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) to…
Important deadline for legacy manufacturers: 26 September 2024
By 26 September 2024, manufacturers of legacy devices must have signed a written agreement with a notified body for MDR CE certification. Before this deadline,…
Switzerland: alignment with IVDR extension and Swissdamed implementation
On 14 August 2024, the Swiss Federal Department of Home Affairs (FDHA) announced Switzerland’s alignment with the EU extension for legacy IVDs, labelling simplification for…
Actors can now register to Swissdamed!
Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is active! Manufacturers, importers, authorised representatives can now register through the…