Human Tissue Authority

The regulator for human tissue and organs

Guidance for professionals

The filter and search function on this page allows you to refine down the full list of guidance that we provide for professionals to find specific items. Common searches for the HTA codes of practice and standards, licensing, fees and inspection information or for specific information for each of our regulated sectors can be found using the menu items above.

Transplant units must use the updated template referral letter when referring a case to the HTA. Please note that we will not accept the old referral letter template.Review of the template referral letter The HTA has reviewed the current template referral letter to promote greater consistency, reduce variability, and to ensure that all referral letters contain relevant donor...
  • Living organ donation
  • Transplants
  • Organ donation and transplantation
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
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
HTA policy on the steps transplant units should take to prepare living organ donors when it is not possible to transplant their organ
  • Living organ donation
  • Transplants
  • Organ donation and transplantation
In part, the Human Tissue Act 2004 was introduced to ensure that living organ donors have made an informed and voluntary decision to donate their organ; free from duress, coercion and reward. Organ trafficking and modern day slavery is a concern for all healthcare professionals.Modern slavery encompasses a broad range of offences including forced labour, domestic servitude and illegal organ...
  • Organ donation and transplantation
  • Transplants
  • Living organ donation
Issued: 14 August 2018Notice for: •    Designated Individuals in the Human Application sector •    Licence contacts in the Organ Donation and Transplantation sector  ScopeThis alert is being issued by the Human Tissue Authority (HTA) and includes information about recent cases of West Nile Virus (WNV) in individuals in Romania and France.Please...
  • Human application
  • Organ donation and transplantation
An overview of the Human Tissue Authority’s (HTA) role in the regulation of post-mortem examination.
  • Inspection
  • Pathologists
  • Post mortem
  • Communication
  • Coroners
  • Governance
  • Mortuaries
Bone marrow and peripheral blood stem cell (PBSC) donation: Legal Framework
  • Bone marrow donation
The Human Tissue Authority (HTA), on behalf of Scottish Ministers, is responsible for assessing all living organ donation cases that take place in Scotland. The HTA also considers allogeneic donation of regenerative tissue where the donor is under 16 or an adult with incapacity in Scotland. Only once HTA approval is in place can these donations go ahead. The Human Tissue (Scotland) Act 2006 (HT...
  • Bone marrow donation
The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (Regulations) require that an AA must have conducted separate interviews with the donor, the person giving consent on the donor’s behalf and the recipient in order to gather the material that must be reported to the HTA.The purpose of the interviews is to ensure that donors are not forced to do...
  • Bone marrow donation

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