Human Tissue Authority

The regulator for human tissue and organs

HTA position statement on the regulation of acellular material.
  • Acellular material
  • Transplants
Research
  • Codes of practice
  • Research
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.The scope of the MDR now includes certain products manufactured utilising derivatives of tissues or cells of...
  • Advanced Therapy Medicinal Products
  • EU tissue and cells directive
  • Human application
West Nile Virus – Bologna and Ferrara Districts, Italy
Further guidance for mortuaries on how to formalise agreements with funeral directors
  • Funeral directors
Reporting obligations and processes regarding SARs and SAEs in HTA licensed establishments
  • Human application
  • Serious Adverse Event or Adverse Reaction (SAEARs)
This document is designed to provide you with information about the Human Tissue Authority (HTA) inspection process, so that you and your staff can prepare for an HTA inspection.• There is a second part of this guidance, covering site visits• The appendix - applicable to both parts one and two - can be downloaded here• The whole document - parts one and two, plus the appendix - can be downloaded...
About the the organ donation and transplantation legislation and framework
  • Governance
  • EU Organ Donation Directive
What is expected of staff in relation to collecting spinal cord and brain tissue
  • Brain donation
  • Post mortem
Guidance on paragraph 135 of the HTA’s Code of Practice on the Human Transplantation (Wales) Act 2013 - excluded relevant material
  • Deceased donation
  • Wales

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