EUDAMED Actor Module Released for Voluntary Use
Released for voluntary use. The EUDAMED Actor Registration Module is not expected to be mandatory until late 2025-early 2026.
Released for voluntary use. The EUDAMED Actor Registration Module is not expected to be mandatory until late 2025-early 2026.
As of today: Any new IVD devices must be CE Marked to the IVDR prior to placing it on the […]
By today, manufacturers of MDD/AIMDD legacy devices must have: implemented a quality management system as outlined in MDR Article 10(9) […]
Manufacturers of MDD/AIMDD legacy devices must have a signed written agreement with a Notified Body by today. This is outlined […]