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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...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2023
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| 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 |