TY  - GEN 
AU  - Aranda, Jesús
AU  - Dobrzynska, Agnieszka
AU  - Rosario-Lozano, Maria Piedad
AU  - Rejón Parrilla, Juan Carlos
AU  - Epstein, David Mark
AU  - Blasco Amaro, Juan Antonio
PY  - 2024
UR  - https://hdl.handle.net/10481/97829
AB  - Introduction: The new European Medical Device Regulation has raised the bar for the clinical evaluation of
medical devices to gain marketing authorization by Notified Bodies (NBs) regarding certificates of conformity
in Europe. Restrictions applied...
LA  - eng
PB  - Taylor & Francis group
KW  - High-risk medical devices
KW  - market approval
KW  - certificates of conformity
TI  - Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review
DO  - 10.1080/14737167.2024.2431234
ER  -