Specific guidance and examples for health technology assessment (HTA) of medical devices
are scarce in medical device development. A more intense dialogue of competent authorities,
HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness.
Especially as the new Medical Device Regulation requires more clinical evidence.We
explore the perceptions of manufacturers, competent authorities, and HTA agencies
towards such dialogues and investigate how they should be designed to accelerate the
translational process from development to patient access using semi-structured interviews.
We synthesized the evidence from manufacturers, competent authorities, and HTA agencies
from 14 different jurisdictions across Europe.Eleven HTA agencies, four competent
authorities, and eight manufacturers of high-risk devices expressed perceptions on
the current situation and the expected development of three types of early dialogues.The
MDR has to be taken into account when designing the early dialogue processes. Transferring
insights from medicinal product regulation is limited as the regulatory pathways differ
substantially.Early dialogues promise to accelerate the translational process and
to provide faster access to innovative medical devices. However, health policy-makers
should promote and fully establish regulatory and HTA early dialogues before introducing
parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating
change, the legislator must create the legal basis and set the appropriate incentives
for manufacturers.
