The European Commission is consulting on the EU legislation on blood, tissues and cells.
The European Commission is consulting on the EU legislation on blood, tissues and cells.
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.
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.
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.
The list provides guidance to the human application sector on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).
In our communication of 8 October we advised that other agencies and organisations were developing specific guidance on the Risks of Transmission of Ebola virus related to donated blood and other substances of human origin (SoHO).
Links
[1] https://www.hta.gov.uk/news/european-commission-consultation-regarding-eu-legislation-blood-tissues-and-cells
[2] https://www.hta.gov.uk/policies/clarification-scope-medical-devices-regulation-tissues-and-cells-products
[3] https://www.hta.gov.uk/policies/clarification-scope-medical-devices-regulation-tissues-and-cells-products-0
[4] https://www.hta.gov.uk/news/government%E2%80%99s-response-consultation-human-tissue-quality-and-safety-human-application-amendment
[5] https://www.hta.gov.uk/news/annual-activity-collection-2017-data-now-open-submissions
[6] https://www.hta.gov.uk/policies/brexit-guidance
[7] https://www.hta.gov.uk/policies/material-covered-quality-and-safety-human-application-regulations
[8] https://www.hta.gov.uk/policies/ebola-virus-%E2%80%93-donor-deferral-guidance-human-application-sector