Professional

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.

The Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) have been working together to reduce the regulatory overlap regarding the storage of ovarian and testicular tissue.

Issued 17 August 2009

It is a requirement of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 that autologous donor serum testing is performed when removed tissues or cells are stored*. The reason for this requirement is to reduce the risk of contamination and transmission of disease through mislabelling or misidentification of tissues or cells. The following mandatory laboratory tests must be performed: Human Immunodeficiency Virus (HIV) 1 & 2, Hepatitis B (core and surface antigen), Hepatitis C and Syphilis.

The Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tissue Authority (HTA) licence. As procurement of cord blood is usually undertaken on Relevant Third Party Premises (RTPP) under a third party agreement (TPA), DIs must develop robust procedures to assure themselves that cord blood is appropriately procured, received, quarantined and risk assessed prior to acceptance into the establishment.