Harmonised standards for aseptic processing and clinical performance studies
On 9 October 2024, the European Commission published new harmonised standards in support of the…
On 9 October 2024, the European Commission published new harmonised standards in support of the…
The Medical Device Coordination Group (MDCG) released MDCG 2024-11, a new guidance to support the…
The NANDO database now includes the NEOEMKI LLC, which brings the total number of notified…
In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses…
By 26 September 2024, manufacturers of legacy devices must have signed a written agreement with…
The NANDO database has a new Notified Body under the IVDR! Istituto Superiore di Sanità…
From 19 August 2024, the European Commission opened a public consultation on common specifications for…
On 14 August 2024, the Swiss Federal Department of Home Affairs (FDHA) announced Switzerland’s alignment…
Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is…
Today, 12 July 2024, the Artificial Intelligence Regulation (AI Act) was published in the Official…
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the…
MDCG 2020-16 on classification rules for IVDs has been updated in July 2024 for its…
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