TY  - RPRT
TI  - Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions
AU  - Hulstaert Frank
AU  - Pouppez Céline
AU  - Primus-de Jong Célia
AU  - Harkin Kathleen
AU  - Neyt Mattias
AB  - KCE Reports 347C (2021)

To obtain marketing authorisation for the European market, any new product must provide evidence of its quality, safety and efficacy. For high-risk medical devices (e.g. implants), the requirements are less strict.
T2  - KCE Reports
CY  - Brussels
PY  - 2021
LA  - English
M3  - Health Services Research (HSR)
PB  - Belgian Health Care Knowledge Centre (KCE)
SN  - 347
VO  - D/2021/10.273/45
DO  - https://doi.org/10.57598/R347C
ER -