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This guide explains the regulatory requirements for establishments in the Human Application sector.
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...
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.
7 December 2015 update: The French Competent Authority issued an update to itsalert. The update noted that additional precautions taken in France following detection of this case of West Nile Virus in October 2015 were no longer in force.
Issued 27 November 2015
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.
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
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.