medicines-medical devices-regulatory affairs
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 14 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 24 September 2021 – 13 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…
Last updated: 21 December 2021 The European Commission (EC) has established a portfolio of the ten most promising treatments for COVID-19. A group of independent scientific experts has screened 82 therapeutic candidates in late stage clinical development and identified 10 candidates as…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 8 May 2020 – 23 September 2021 is covered. On mobile, the table is best…
A new, sensitive COVID-19 test produces sample-to-signal in under ten minutes. Researchers from the University of Birmingham have confirmed the speed, accuracy and simplicity of a novel, highly sensitive testing method for COVID-19 that can be deployed at entertainment venues,…
An Artificial Intelligence (AI) powered device able to detect SARS-CoV-2 (the virus that causes COVID-19) within 20 seconds is currently under UK MHRA assessment. What is the test called? The device is called SpectraLIT. Who has developed this test? The SpectraLIT device…
The EU Strategy on COVID-19 Therapeutics delivered an announcement from the EU commission on the first portfolio of five therapeutics that could soon be available to treat patients across the EU. Monoclonal antibodies The four newly developed monoclonal antibodies under…
The European Medical Devices and Coordination Group (MDCG) has endorsed a notice on the impact of genetic variants on SARS-COV-2 IVD medical devices. The notice (MDCG 2021-7) is addressed to manufacturers and authorised representatives of in vitro diagnostic medical devices (IVDs) with…
A Finnish company, Deep Sensing Algorithms has developed a rapid COVID-19 breath test device. What is the device called and what type of device is it? ? DSA BreathPass™ is a handheld breath analysing device intended for the detection of…