Clinical Regulation

NHS Blood and Transplant (NHSBT) is accountable to the Department of Health for the standard of products and services we provide.

We are regulated by a number of external regulatory agencies including the Care Quality Commission (CQC), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Human Tissue Authority (HTA).

The CQC monitor and regulate compliance with the requirements of the Care Quality Commission (Registration) regulations 2009 and the Health and Social Care Act (Regulated Activities) Regulations 2014, which includes the Fundamental Standards. These are the standards which the provision of regulated activities and care must not fall. The MHRA are responsible for the regulation of medical devices and medicines used in healthcare and also the regulation of blood establishments. The HTA regulate organisations that remove, store and use tissue, including organs for transplantation.

NHSBT has in place, established processes to ensure compliance with each standard and regulatory requirement as part of its ongoing commitment to providing high quality products and services.

Useful Links



Downloads and useful links