In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses…
IVDR: 13th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Istituto Superiore di Sanità…
Public consultation on common specifications for IVDs
From 19 August 2024, the European Commission opened a public consultation on common specifications for…
Switzerland: alignment with IVDR extension and Swissdamed implementation
On 14 August 2024, the Swiss Federal Department of Home Affairs (FDHA) announced Switzerland’s alignment…
Actors can now register to Swissdamed!
Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is…
Artificial Intelligence Act just released
Today, 12 July 2024, the Artificial Intelligence Regulation (AI Act) was published in the Official…
MDR and IVDR changes officially published
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the…
Updated guidance on classification rules for IVDs
MDCG 2020-16 on classification rules for IVDs has been updated in July 2024 for its…
Updated guidance on standardisation for medical devices
In July 2024, the Medical Device Coordination Group (MDCG) updated its guidance MDCG 2021-5 on…
Council formally adopts amendments to MDR and IVDR
Today, 30 May 2024, the Council formally adopted the new rules to amend the Medical…