Introduction to the Regulations
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regs) transpose the European Union Tissue and Cells Directives (EUTCDs) into UK law. The purpose of the Directives is to establish a harmonised approach to the regulation of tissues and cells across Europe.
Find out more about the EU Tissue and Cells Directives here.
Role of Designated Individual
Designated Individuals (DIs) have a key role to play in ensuring compliance with the requirements of the Q&S Regulations. You can find more information about DIs responsibilities under the Q&S Regulations here.
Reporting Serious Adverse Events and Reactions (SAEARs)
You are required to report serious adverse events (SAEs) or serious adverse reactions (SARs) to the HTA within 24 hours of discovery.
Find out more about SAEARs and how to report here.