MDCG: Ethylene Oxide in medical devices and Borderline Classification
In October 2024, the MDCG published two documents: one on the regulatory status of ethylene…
In October 2024, the MDCG published two documents: one on the regulatory status of ethylene…
In its recent Regulation (EU) 2024/1860, the European Commission introduced amendments to the Medical Devices…
Today, 23 October 2024, the European Parliament votes in favour of a resolution to update…
MDCG just updated its guidance document on the application of MDR requirements to legacy devices…
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…
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