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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.
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.
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.
Faecal microbiota transplants (FMT) are recognised as an emerging treatment for recurrent Clostridium difficile infections in patients where antibiotic and other lines of treatment have failed.
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.
These guides set out your basic rights when dealing with an establishment regulated by the HTA.
7 December 2015 update: The French Competent Authority issued an update to itsalert. The update noted that additional precautions taken in France following detection of this case of West Nile Virus in October 2015 were no longer in force.
Issued 27 November 2015
CONSULTATION NOW CLOSED.
For more ifnromation, please see our current Codes of Practice and Standards