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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 HTA and MHRA have agreed to extend their existing policy relating to dendritic cells. This extended policy will allow collection of blood as a starting material for an ATMP to be performed under either a Tissues and Cells or Blood Establishment Licence.
The HTA expects establishments to follow the advice provided by the advisory bodies, relevant to the sector in which they operate.
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 European Commission has launched the web-based EU Coding Platform. The platform is free to access and is designed to help build the Single European Code (SEC) to be allocated and applied to tissues and cells.The EU Coding Platform contains two compendia:
Issued 2 November 2016
Notice for
• Designated Individuals (DIs) in the Human Application (HA) sector • Licence contacts in the Organ Donation and Transplantation (ODT) sector
Issued 10 May 2017
Notice for
• Designated Individuals (DIs) in the Human Application (HA) sector
Scope
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.
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 HTA was asked for details of serious adverse events and reactions (SAEARs) across multiple types of human application activities, broken down by year.