Surprise EU human tissue regulatory development
This article was originally published in Clinica
Executive Summary
Medical device industry representatives working on human tissues in the EU have been surprised to learn that a new player is becoming involved in one aspect of regulating the area. Although discussions are still at a preliminary stage, the European Commission's Directorate General (DG) Sanco, responsible for health and consumer protection, is working on a proposal for a directive on the safe sourcing and quality of human tissue materials.