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Issued March 2010 Umbilical cord blood (cord blood) is collected at the time of birth and stored so that it may be available for potential future treatment of the child or another person.
EU Directives are being put in place for the coding and import of tissues and cells for human application (HA). These will be transposed into UK law during 2016 and the process of writing the UK Regulations is underway.Copies of these Directives and an overview from the Department of Health (DH...
The Human Tissue Authority (HTA) welcomes the publication of the report from the Regenerative Medicine Expert Group, “Building on our own potential: a UK pathway for regenerative medicine”.
HTA-licensed establishments in the post mortem sector are required to report incidents (HTARIs), and those in the human application and organ donation and transplantation sectors are required to report serious adverse events or reactions (SAEARs), as part of their licensing with us.
This policy has been developed by the HTA in order to provide clarification and to assure consistency in the way licensed establishments apply the mandatory testing requirements for HTLV-1 testing.
The HTA is the UK Competent Authority for the purposes of the EU Tissues and Cells Directives, which set standards of quality and safety in relation to human tissues and cells intended for human application.
Issued 2 November 2016
• Designated Individuals (DIs) in the Human Application (HA) sector • Licence contacts in the Organ Donation and Transplantation (ODT) sector
Issued 10 May 2017
• Designated Individuals (DIs) in the Human Application (HA) sector
The European Commission is consulting on the EU legislation on blood, tissues and cells.
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.