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Notice for
• Designated Individuals in the Human Application sector • Licence contacts in the Organ Donation and Transplantation sector
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.
Notice for
• Designated Individuals in the Human Application sector • Licence contacts in the Organ Donation and Transplantation sector
• Designated Individuals in the Human Application sector • Licence contacts in the Organ Donation and Transplantation sector
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.
• Designated Individuals in the Human Application sector • Licence contacts in the Organ Donation and Transplantation sector
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.
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.