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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.
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 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.
This guide explains the regulatory requirements for establishments in the Human Application sector.
Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations), the HTA licenses and inspects establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human...
Please note that if you are not undertaking activities relating to material for human application - for example, you carry out organ donation and transplantation, post mortems or anatomical examinations - this system is not applicable to you.