In today’s video, I will briefly answer the following question:
“How is the approval process of Ethics Committees harmonized under the MDR?”
Ethics committees are responsible for evaluating a clinical investigation and determine whether ethical principles are being met. Requirements related to ethics committee composition and function are not specified in the MDR – however, the MDR requires that ethical review of a clinical investigation must be performed by an ethics committee in accordance with national law.
The MDR also requires that Member States must ensure that the procedures for review by ethics committees are compatible with the procedures set out in the MDR, and that at least one lay person must participate in the ethical review.
However, the approval process of the ethics committee is not harmonized by the MDR. This has led to variability in ethics committee procedures and required documents within the same country, but also among different countries. The specific ethics committee that is required for approving a study also varies.
To harmonize the approval process in the EU, the latest version of the ISO14155 provides guidance for ethics committees on best practices for the operation of the ethics committees involved in the review of the clinical investigations.