Clinical Aspects

Understanding The Technical, Biological, And Clinical Aspects Of Demonstrating Equivalence The MDR (Annex XIV, Part A) emphasizes the importance of considering technical, biological, and clinical characteristics when demonstrating equivalence to other devices. The demonstration of equivalence must adhere to the requirements outlined in Part A, section 3 of Annex XIV of EU-MDR. Annex XIV part A requires that the manufacturer should demonstrate that there are no clinically significant differences in safety or clinical performance with regard to technical, biological and clinical characteristics. MEDDEV 2.7/1 Rev. 4 is a guidance document that provides guidance on clinical evaluation in the European Union. However, because [...]