Medical Device / IVD Classification

Medical devices classification can sometimes be very straightforward, but sometimes it can also be complicated. Uncertainties may appear whether your device is even a medical device or an in vitro diagnostic device, especially when dealing with the so called borderline products, or in which class of medical devices your device would fall. No matter how complicated the case, we can help you with your device classification. We can also obtain an official classification for your devices from the national competent authority.

Contact us to find out more about the Medical device / IVD classification and to receive a quote.

Other related links:

• Authorized Representative Service for CE Certified Devices
• Vigilance system implementation
• Guidance on labelling requirements
• ¿Cómo afectará el Reglamento Europeo a la vigilancia de Productos Sanitarios?
• Solicitud del Código Nacional de Parafarmacia
• Comunicación de puesta en el mercado de productos sanitarios
• Registro de Responsables de la puesta en el mercado de productos sanitarios
• Licencia previa de funcionamiento de instalaciones de productos sanitarios: fabricación, esterilización, agrupación e importación
• Importación de productos sanitarios
• Sistema de vigilancia de productos sanitarios
• Licencia de fabricación de productos sanitarios a medida

Update date: 15-06-2015