WP6 Early dialogue and early assessment of medical devices

WP6 is led by KPM Center for Public Management, and intends to identify novel approaches for the assessment of medical devices early in their development stages (i.e. pre-market stages), to provide best-practices, new methods, procedures, and tools for a successful early dialogue between regulators, HTA agencies and manufacturers.

Objectives:

• » To investigate current activities of early dialogue between manufacturers, regulators, and HTA decision-makers concerning innovative medical technologies;
• » To develop methods and guidelines that can be applied in early dialogue processes;
• » To analyse the role of early assessment of innovative medical technologies for informed policy decision making.

Outcomes:

• » A report on the results of the survey conducted to evaluate current knowledge, perceptions and expectations of different stakeholders around the early assessment of medical devices will be produced.
• » Policy recommendations will be developed based on the development of a device-specific framework on the HTA agencies’ and regulators’ information needs that accounts for the diverse characteristics of medical devices.