European Commission does U-turn on human tissue regulation
This article was originally published in Clinica
Executive Summary
Tissue-engineered products containing non-viable human tissues and cells may now be excluded from the long-awaited human tissue-engineered product Regulation being drafted by the European Commission's Directorate General Enterprise. Industry learnt of the surprise turnaround during a meeting with the Commission on June 23, Shayesteh Furst-Ladani, chair of the cell and tissues working group at industry association EuropaBio, told the 12th annual ABHI/IBC Global Conferences meeting on Medical Device Regulation, on June 24.