Jul 24, 2020
Please see below a link to the slides from the NIHR-hosted webinar on the new COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) platform that will evaluate the performance of new diagnostic tests in the settings they have been developed to be used in. The Webinar took place on 15th July 2020.
Jul 16, 2020
Your Chance to Modify the BIVDA Market Audit (Coronavirus included).Does your company participate in the BIVDA Market Audit? 95% of the industry turnover is represented in this comprehensive, twice-yearly audit, and participants benefit by receiving detailed analysis of market sizes and trends down to the level of individual test types and technologies.Every year the MedTech Europe Market Research Committee look at the Global IVD (GIVD) Classification which is used for the BIVDA Market Audit as ...
Jul 15, 2020
MedTech Europe has flagged concerns over the implementation of the IVDR framework which is due to take effect in 2022. The trade association is ‘raising the alarm’ over a lack of preparedness for the implementation of the policy across Europe. Guidance documents, EU reference laboratories and common specifications which are key to the implementation of regulatory policies do not currently exist according to the organisation. MedTech’s CEO Serge Bernasconi said that “MedTe...
Jul 14, 2020
Members can find a guest blog from NAMSA covering all aspects of the IVDR compliance roadmap at the link here.
Jul 07, 2020
The Abingdon Health-led UK Rapid Test Consortium has reached a ‘design freeze’ for its proposed antibody test model after ten weeks of work. The group is composed of UK scientists and manufacturers who have been working since April to respond to the Department of Health and Social Care’s call for antibody test procurement. Professor John Bell, Regius Professor of medicine at Oxford University, asked Abingdon Health to work with experts at Oxford to begin the development process...
Jul 01, 2020
As part of its ‘Delivering Core NHS and Care Services during the Pandemic and Beyond’ inquiry, the Health and Social Care Select Committee held an oral evidence session this week. A range of topics were covered at the event, including testing and PPE, resumption of elective care, diagnostics and mental health. Sir Simon Stevens of NHS England was present as a witness and made a series of points regarding the ways the NHS could expand its diagnostic capacity. This expansion is especia...
Jun 22, 2020
The Faculty for Pharmaceutical Medicine has prepared a text on understanding the science and current approaches surrounding COVID-19 diagnostic testing. The piece is authored by Robert L Holland FFPM and John Bagshaw, Interim Chief Operating Officer of the BIVDA. As part of its contents, the piece addresses the purposes of testing, the science behind diagnostic methodologies and any limitations of certain approaches.
Jun 17, 2020
As part of the Welsh strategy of NHS Test and Trace, there will be a dedicated COVID-19 testing laboratory established in Cardiff. This is due to a collaboration between Public Health Wales and diagnostics company PerkinElmer. The University Hospital of Wales will be the new site for these testing efforts which will bolster the country’s capacity to deliver prompt testing services which form the basis of effective Test and Trace practice. Life Sciences Hub Wales issued a call-to-action amo...
Jun 12, 2020
Please see attached the latest bulletin from the Office for Life Sciences.
Jun 09, 2020
Advances have been made in the progression of the Medicines and Medical Devices Bill through Parliament as yesterday the Public Bill Committee met to discuss the Bill as well as amendments put forward by opposition Committee members. The topics discussed were human and veterinary medicines alongside the beginnings of discussions on the medical devices sections included in the legislation. Labour committee members stated their support for the Bill in light of the UK’s withdrawal from the EU...