The Challenges of Setting Up a Clinical Study with the New European Union Medical Device Regulation

Acta Med Port. 2023 Jul 3;36(7-8):455-457. doi: 10.20344/amp.19423. Epub 2023 May 26.

¹ Fraunhofer Portugal AICOS (Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions). Porto; Faculdade de Medicina. Universidade do Porto. Porto. Portugal.
² Department of Ophthalmology. Centro Hospitalar Universitário Lisboa Central. Lisbon; NOVA Medical School. Universidade NOVA de Lisboa. Lisbon; Portuguese Retina Institute. Lisbon. Portugal.
³ Fraunhofer Portugal AICOS (Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions). Porto. Portugal.

No abstract available

Keywords: Clinical Research; European Union; Medical Device Legislation.

MeSH terms