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All establishments licensed for patient treatment under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 must submit data relating to the activities they undertook and the tissue types they worked with in 2017.
The Department of Health and Social Care has published guidance for industry and organisations involved in health and care about plans for a no-deal Brexit.
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...
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.
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For more ifnromation, please see our current Codes of Practice and Standards
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.
The European Commission is consulting on the EU legislation on blood, tissues and cells.
The HTA would like to thank establishments in the HA sector for the prompt completion and return of the HA sector COVID-19 questionnaire at such a challenging time.
Today the Department of Health (DH) has published the Government’s response to the consultation on Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017.