Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region.
Latest Glossary Definitions
The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for each Consultation. In the case of Consolidated Parallel Consultations, all EDWP members and a maximum of 3 other HTA members (from EUnetHTA WP5) will participate.
Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs. Once the decision to proceed with a Consolidated Parallel Consultation has been taken, the EUnetHTA ED Secretariat begins the process of recruiting additional HTABs to compose the EDC.
Individual Parallel Consultations are supported by the EUnetHTA ED Secretariat, thereby benefiting from HTA scientific and administrative coordination with centralised HTA recruitment, consolidated HTA comments and List of Issues, albeit with individual HTA written reports as the final product.
A "medical device software”, refers to a computer application that meets the legal definition of a medical device and is not a part of any distinct product.
Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.
Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.
The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class III. De novo process allows these low risk devices to be re-classified via a request for a risk-based (re)classification from the FDA.
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.