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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.
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 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
Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).
The Human Tissue Authority (HTA) welcomes the publication of the report from the Regenerative Medicine Expert Group, “Building on our own potential: a UK pathway for regenerative medicine”.
The Regulatory Advice Service for Regenerative Medicine (the Advice Service) is a ‘One Stop Shop’ for research and development professionals across academia, industry, and the NHS. It offers a single point of access to free, clear, expert responses to queries about the regulation of regenerative...
The aim of regulating human embryonic stem cells is to ensure that the highest standards are met from their derivation in the laboratory through to their clinical application.
Umbilical cord blood may be collected at the time of birth and stored, so that it is available for potential future treatment of the child or another person.
According to the 2013 House of Lords report on Regenerative Medicine, the term ‘regenerative medicine’ refers to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function.