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

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 applications...

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Detalles Bibliográficos
Autores principales: Hulstaert, Frank, Pouppez, Céline, Primus-de Jong, Célia, Harkin, Kathleen, Neyt, Mattias
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Position Statement
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10369713/
https://www.ncbi.nlm.nih.gov/pubmed/37491269
http://dx.doi.org/10.1186/s13023-023-02801-7

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10369713/
https://www.ncbi.nlm.nih.gov/pubmed/37491269
http://dx.doi.org/10.1186/s13023-023-02801-7

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