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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.
These guides set out your basic rights when dealing with an establishment regulated by the HTA.
Are you considering banking your baby’s umbilical cord blood? Have you come across our cord blood-banking guide before?
The European Commission is consulting on the EU legislation on blood, tissues and cells.
Issued 10 May 2017
• Designated Individuals (DIs) in the Human Application (HA) sector
Issued 2 November 2016
• Designated Individuals (DIs) in the Human Application (HA) sector • Licence contacts in the Organ Donation and Transplantation (ODT) sector
The HTA was asked to share a letter written to the University of Bristol regarding a process taking place at the university in 2008, as part of a process to create an artificial trachea for transplant
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.
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.
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that additional precautions taken in France following detection of this case of West Nile Virus in October 2015 were no longer in force.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