Performance studies

• February 5 2025
• Medical technology
• Clinical Studies
• Performance Studies
• June 02, 2023

• Application of Regulation (EU) 2017/746 to clinical performance studies of In Vitro Diagnostics
• Initial Application for a prospective clinical investigation or performance study under the MDR or IVDR (Special Part)
• Application for Modification of a clinical investigation or performance study under the MDR or IVDR (Special Part)