Acceso al mercado europeo para MedTech

Your European market entry strategy depends on your starting point. Regulatory expectations, clinical evidence requirements, and typical EU entry risks vary significantly between US and Chinese MedTech manufacturers. We tailor your EU entry strategy based on your regulatory background, clinical maturity, and business objectives.

Desafíos clave que abordamos

De FDA o NMPA a MDR/IVDR

Comprende las diferencias regulatorias clave de la UE, traduce tu evidencia clínica, adapta los datos existentes y planifica una vía con el Organismo Notificado.

Análisis de brechas y documentación

Identifica brechas, optimiza la documentación y reduce el tiempo de llegada al mercado con orientación regulatoria experta.

Cumplimiento sostenible

Logra un cumplimiento sostenible con gestión del ciclo de vida y soporte de vigilancia poscomercialización.

Tu socio de confianza para la entrada en el mercado de la UE para Medical Devices e IVDs.

Vía regulatoria

Navega el MDR y el IVDR con orientación experta.

• Clasificación de producto y estrategia regulatoria
• Documentación técnica y preparación para el Organismo Notificado
• Análisis de brechas y planificación de remediación

Evidencia clínica

Construye la estrategia de evidencia clínica adecuada.

• Preparación de informes de evaluación clínica
• Diseño y ejecución de estudios PMCF
• Revisión bibliográfica y evaluación de equivalencia

Alineación del QMS

Alinea tus sistemas de calidad con las expectativas de la UE.

• Evaluación de brechas e implementación de ISO 13485
• Alineación de controles de diseño y gestión de riesgos
• Cualificación de proveedores para requisitos de la UE

Cumplimiento poscomercialización

Mantén el cumplimiento durante todo el ciclo de vida.

• Planificación de vigilancia poscomercialización
• Informes de vigilancia y preparación de PSUR
• Gestión de actualizaciones periódicas de seguridad

Multi-Country Clinical Trial for CE-Mark Success in the UK

Navigating complex UK regulations to deliver a seamless, multi-country clinical trial for coronary artery disease

• Challenge: Client needed critical data for their CE-mark application through a multi-country clinical trial, facing the complexities of navigating UK regulatory requirements, which many companies avoid due to its challenges.
• Approach: Full support for the LiquID Safety study from start-up to closure. Study monitoring, regulatory submissions, and project oversight. Streamlined UK submission processes and leveraged top-tier UK investigational sites for the study.
• Result: The study enrolled 86 subjects across Belgium, UK, and Scotland, and was completed successfully in Q1 2024. Demonstrated the value of UK investigational sites in a First-in-Human trial for coronary artery disease. The positive outcome led to further collaborations, with the client recommending our services to other clients.

Empowering a First-In-Human Clinical Trial Success

Expert guidance and seamless project management for breakthrough medical innovations in heart failure treatment

• Challenge: Client faced difficulties navigating the complex EU regulatory landscape to set up and manage their first multi-country clinical trial for the V-LAP System, without prior EU trial management experience.
• Approach: Initially covered the UK, expanding to Spain and offering consultancy and project management support. Assigned experienced CRAs for trial monitoring, regulatory submissions, and document creation. Provided comprehensive advisory services to ensure compliance with EU standards.
• Result: 30 subjects enrolled across five countries for the ongoing First-in-Human study. Successful start-up phase completion and knowledge transfer enabled Vectorious to manage many trial aspects independently. Strong collaboration led to future project opportunities through industry referrals.