Scientific advice

Scientific advice (SA) is the most formal and detailed form of interaction between health technology developers and regulatory or HTA agencies.

This process involves comprehensive consultations to address scientific and technical questions related to the development, regulatory approval, and post-market surveillance of health technologies.

Scientific advice is crucial for ensuring that the device development aligns with regulatory or reimbursement expectations and scientific standards. It is the last step within a chain starting with Early dialogues and Early Advices to assure awareness of all requested requirements for market access.