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…
New Guidance on qualification of IVDs
The Medical Device Coordination Group (MDCG) released MDCG 2024-11, a new guidance to support the qualification of in vitro diagnostic medical devices and assess whether…
Transitional provisions for Class D IVDs: Updates to MDCG 2021-4
In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D…
IVDR: 13th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Istituto Superiore di Sanità is the 13th EU Notified Body notified under the Regulation…
Public consultation on common specifications for IVDs
From 19 August 2024, the European Commission opened a public consultation on common specifications for certain vitro diagnostic medical devices. For four weeks, until 16…
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…
Artificial Intelligence Act just released
Today, 12 July 2024, the Artificial Intelligence Regulation (AI Act) was published in the Official Journal of the European Union. Regulation (EU) 2024/1689 sets harmonised…
MDR and IVDR changes officially published
Today, 9 July 2024, Regulation (EU) 2024/1860 was listed in the Official Journal of the EU. After the Council approval on 30 May, the latest…
Updated guidance on classification rules for IVDs
MDCG 2020-16 on classification rules for IVDs has been updated in July 2024 for its third revision. The second update came in February 2023 with…