Medical Device Development.

Medical Device Classification

The classification of medical devices is a crucial step in medical device development, as it defines the regulatory pathway required for market authorization. Devices are categorized into risk-based classes — Class I, IIa, IIb and III — based on their intended use, degree of invasiveness and potential risks, according to frameworks such as EU MDR Annex VIII or FDA guidelines. At OLIFEO, we support device owners in this critical step by seamlessly integrating requirements engineering, stakeholder frameworks and future architecture and validation planning to align technical and regulatory objectives from the outset. For Class II and Class III products, we facilitate efficient collaboration with the EU Notified Body in Italy to ensure a smooth review and approval process. By managing these complex tasks, we provide a streamlined path to regulatory compliance while ensuring precision and foresight at every stage of medical device development.