Labelling is one of the most important components of the product both in terms of sales, and in terms of compliance with the EU Medical Devices Directive 93/42/EEC (MDD), Active Implantable Medical Device Directive 90/385/EEC (AIMDD) or In Vitro Diagnostic Medical Device Directive 98/79/EC (IVDD). Many companies are having problems determining the labelling requirements; which information has to appear on the product labeling, what is required, what isn’t, and what is prohibited.
Revipharm can provide guidance on the labeling requirements and review your labels to ensure their compliance with the applicable legislation.
Contact us to find out more about the Guidance on labelling requirements and labelling review service and to receive a quote.
Other related links:
- Authorized Representative Service for CE Certified Devices
- Medical Device / IVD Classification
- Vigilance system implementation
- ¿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
