Professional

Medical school staff are sometimes faced with the challenge of deciding whether the consent given by potential donors, often many years before their death, is valid if it contains colloquial terminology and not the specific terms stated in the Human Tissue Act 2004 (the HT Act). This document aims to provide guidance on the circumstances under which the consent may be deemed acceptable and can be acted upon.

New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.

Importing tissue establishments must ensure that imports from third countries meet standards of quality and safety equivalent to those in the UK. The majority of imports originate in the US and we have identified a number of key differences in regulatory requirements.

Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP). 

Faecal microbiota transplantation (FMT) is recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic and other lines of treatment have failed.

FMT is outside the scope of the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) and is not regulated by the HTA.

Establishments seeking to perform FMT should contact the MHRA Medicines Borderline Section for further advice.

This is the joint position from the Human Tissue Authority (HTA), Human Fertilisation and Embryology Authority (HFEA) and Medicines and Healthcare products Regulatory Agency (MHRA). The aim of regulating human embryonic stem cells (hESCs) is to ensure that the highest standards are met from their derivation in the laboratory through to their clinical application.