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In the Human Application sector, a Third Party Agreement (TPA) may be used to provide an unlicensed third party with the authority to undertake licensable activities on behalf of an appropriately licensed establishment.
If the UK leaves the EU without a deal, it will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directives.
The Department of Health and Social Care has published guidance on EU Exit Operational Readiness on actions the health and care system in England should take to prepare for a ‘no deal scenario’.
The HTA portal is open to collect annual activity data from all establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
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.
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.
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.
These guides set out your basic rights when dealing with an establishment regulated by the HTA.