Meet us in Long Beach at RAPS Convergence 2024! Join our session and visit booth #1013 to discuss strategies for navigating MDR, IVDR, and UDI requirements. #RAPSConvergence #EUDAMED #MedicalDevices #USDM

Updates! Struggling to keep up with the new IVDR transitional period? operonstrategist.com/regulation-eu-… Get connected: Mail ID: [email protected] Phone no: +91 9370283428 . . . #IVDR #MedicalDevices #RegulatoryCompliance #EUDAMED #IVD #MedicalDeviceRegulations

Do you need help understanding this new amendment and its details or support in implementing the new regulation? Reach out to us for hand-on guidance ☞ [email protected] 5/5 #medicaldevices #IVDs #Eudamed #EUregulation #patientcare #healthcare #healthcareinnovation

➢ Phased Rollout of #Eudamed: The European #database on #medicaldevices will be introduced in stages as its electronic systems become operational. This phased approach will minimize disruption for manufacturers and #notifiedbodies. 4/5

➢ Extended Transitional Periods for #IVDs: To address delays in #Eudamed's clinical investigation system development and limited #notifiedbody capacity, the transition period for certain #IVDs has been extended. This extension aims to prevent shortages. 3/5 #medicaldevices

The European Parliament has implemented Regulation (EU) 2024/1860, introducing amendments to the regulations governing #medicaldevices and #IVDs. 1/5 eur-lex.europa.eu/legal-content/… #medicaldevices #IVDs #Eudamed #EUregulation #patientcare #healthcare #healthcareinnovation

❗ Regulation (EU) 2024/1860 on #Eudamed and #IVD is now in the #OJEU OJ L 2024/1860, 9.7.2024 eur-lex.europa.eu/eli/reg/2024/1… 👉 For more, see European Commission EU One Health DG #SANTE page health.ec.europa.eu/medical-device… #EU #Regulations #MedicalDevices #MDR #InVitroDiagnosticMedicalDevices #IVDR

Join this insightful webinar & learn a practical approach to UDI strategy for product data submissions to EUDAMED, and other best practices to streamline regulatory processes for compliance. Save your seat: bit.ly/3zCPedn. #medtech #eudamed #udi #eumdr #greenlightguru

EU has published new guidelines for clinical evaluation of orphan medical devices under MDR 2017/745, aiming to streamline processes, support manufacturers, and ensure quicker patient access to crucial treatments for rare diseases.🩺🔍 👉ec.europa.eu/newsroom/sante… #EUDAMED #HealthEU

Last chance to join tomorrow's webinar to learn how to prepare your team and data for managing UDI data to meet the EUDAMED submissions deadline. Register now: bit.ly/4eBA8ow #LifeSciences #MedicalDevices #EUDAMED #UDI #MedicalDevicesRegulation

Join our webinar on July 2nd to learn how to plan and prepare your team and data for managing UDI data to meet the EUDAMED submissions deadline. Learn more and register here: bit.ly/4eBA8ow #LifeSciences #MedicalDevices #EUDAMED #UDI #MedicalDevicesRegulation

📢 #MDnews: El Consejo Europeo adopta nuevas medidas para ayudar a prevenir la escasez y facilitar la transición hacia una mayor transparencia y acceso a la información. 🙄 🔗Lee la noticia completa aquí: hubs.li/Q02B3Y1q0 #AmbitBST #MedicalDevices #IVDR #Europe #EUDAMED

📢 MD News: La AEMPS publicó su Boletín de Dispositivos Médicos. 📄 🔗Para ver el documento completo, haz click aquí: bit.ly/4efDrSu #AmbitBST #MedicalDevices #MDnews #EUDAMED #AEMPS

Rada 🇪🇺 schválila nařízení o zdravotnických prostředcích a o zdravotnických prostředcích in vitro. Nová úprava tak nově zajistí: 👉🏼postupné spouštění databáze #EUDAMED 👉🏼dostupnost vysoce rizikových zdravotnických prostředků in vitro #EUHealthUnion #MDR #IVDR

💥MDCG 2022-4 Rev 2  May 2024💥Guidance on appropriate surveillance regarding the transitional provisions under Article 120 ...MDR ... the MDD or the AIMDD. Source: health.ec.europa.eu/document/downl… #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED

🔹Gradually implementing the #Eudamed, making parts of it mandatory from early 2026 to enhance market transparency. The Council will formally adopt these regulations, which will then take effect upon publication in the Official Journal of the #EuropeanUnion. 4/5 #EURegulations

Explore regulatory documentation complexities for medical & in vitro diagnostic device manufacturers, especially with #EUDAMED. Learn common reasons for market approval delays and a data-driven approach to content management in RWS Group's webinar: buff.ly/4bwoXv4