EN ISO 14155:2020 is a standard that has not yet been harmonized for the MDR. It is titled “Clinical investigations of medical devices for human subjects – good clinical practice.” It describes the state of the art for medical device manufacturers in preparing, planning, conducting, and evaluating clinical investigations. It also determines the responsibilities of…
DetailsThe term “clinical validation” is also frequently used in the context of medical devices. For example, the German Federal Ministry of Education and Research (BMBF) has published a guideline on the clinical validation of innovative medical technology solutions (only available in German). The FDA also refers to clinical validation. What is clinical validation? What distinguishes…
DetailsThe requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here.
