EC moves human tissue products from devices to biotech unit
This article was originally published in Clinica
Executive Summary
The European Commission has taken a decision that should give a fresh impetus to the development of EU legislation on human tissue engineered products. Responsibility for developing the new rules has moved from the medical devices unit of Directorate G of the European Commission's Directorate General Enterprise to the biotechnology unit of Directorate F, under head of unit Abraao Carvalho. Both cover single-market issues with Directorate G focusing on the regulatory environment, standardisation and new approach, while Directorate F is responsible for the management and legislation of consumer goods and is also home to the pharmaceuticals unit.