CyberActa reposted this
📢 Just published - new guidance for medical devices used in combination with medicines 💉 💊 🤝 The document will guide marketing authorisation holders, applicants and notified bodies through some of the changes introduced by the medical devices and in-vitro diagnostics regulations. 🔍 What's inside: ➡ insights on integral drug-device combinations and their lifecycle management ➡ labelling requirements for medical devices co-packaged with medicinal products ➡ information on the consultation procedures for medical devices with ancillary medicinal substances and companion diagnostics Find out more: https://lnkd.in/d6wjy5KN #medicines #MedicalDevices #InVitroDiagnostics #CompanionDiagnostics
🙏 Thanks for the clarification regarding Companion Diagnostics. Especially IVD manufacturers 🔬 and medical laboratories 👩🔬 involved in the development of CDx should definitely read the new chapter 5.
Very helpful!
Thanks for sharing
Great advice! Marco sempre interventi di spessore. Bravo e grazie! 👏 💪
Most of the time, cell and gene therapies are leading to personalized medicines, mandating companion diagnostics as well.