Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

Abstract Aim To determine the level of evidence for innovative high-risk medical devices at market entry. Methods We reviewed all Belgian healthcare payer (RIZIV-INAMI) assessor reports on novel implants or invasive medical devices (n = 18, Class IIb-III) available between 2018 to mid-2019 on applic...

Full description

Bibliographic Details
Main Authors: Frank Hulstaert, Céline Pouppez, Célia Primus-de Jong, Kathleen Harkin, Mattias Neyt
Format: Article
Language:English
Published: BMC 2023-07-01
Series:Orphanet Journal of Rare Diseases
Subjects:
Medical devices
Evidence gaps
CE marking
Reimbursement
Declaration of Helsinki
Comparator
Online Access:https://doi.org/10.1186/s13023-023-02801-7

Internet

https://doi.org/10.1186/s13023-023-02801-7

Similar Items