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📢 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

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Most of the time, cell and gene therapies are leading to personalized medicines, mandating companion diagnostics as well.

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Ulrich Hafen

🔬 Supporting medical laboratories towards IVDR compliance and efficient QM systems. | IVDR & QM Consultant for laboratories & manufacturers @ Johner Institut GmbH

3mo

🙏 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.

Sohoo. Mujeeb ur Rehman

Lecturer in Histology, Department of Anatomy and Histology (Biomedical Sciences) at PMAS - Arid Agriculture University Rawalpindi

3mo

Thanks for sharing

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Riccardo Cianchi

Lega del Filodoro Volunteer Supporter - Greater Rome Metropolitan Area

3mo

Great advice! Marco sempre interventi di spessore. Bravo e grazie! 👏 💪

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Kampadilemba Ouoba

PhD Droit et Réglementation pharmaceutiques

3mo
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