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Natalie Creaney

ConsultationsConsultations Archive

NICE: Help shape our new regulatory service

NICE has launched an early version of their new service which maps out the regulatory and health technology assessment pathway for AI and digital technologies. They invite interested parties whether you are an adopter or developer – looking to either create or implement new technologies – to ‘test’ the site and provide feedback. The website, titled ‘Understanding regulations of AI…
Natalie Creaney
August 19, 2022
Membership NewsMembership News Archive

BIVDA interview published in Medtech Insight

Doris-Ann and Ashleigh recently met with Medtech Insight to talk about the upcoming changes to regulation of IVDs in the UK. This article has now been published, titled “Vibrant IVDs Innovation Climate At Risk From Poor UK Regulatory System Readiness”, and features our concerns and highlights in relation to the UKCA regulatory framework. The full article can be found here…
Natalie Creaney
August 19, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

MHRA to change method of reporting adverse events

On 18 August, MHRA held a webinar to explain what changes are coming in how adverse events vigilance reports should be submitted. The current MORE reporting system is being updated to a new MORE system. This means that adverse event reports must be submitted using this new system from November 2022 or via MHRA’s custom API for direct submission through…
Natalie Creaney
August 19, 2022
ConsultationsConsultations Archive

NHS Digital: Learning Networks Survey

The Digital Diagnostics Capability (DDC) programme was set up to help deliver the consolidation of diagnostics services identified in the NHS Long Term plan and support the initiatives of improving connectivity and digitisation identified in the Sir Mike Richards Diagnostics Review 2020. The DDC programme is working to improve the information quality of diagnostics service outputs to improve the provision of…
Natalie Creaney
August 19, 2022
HighlightsHighlights Archive

Media Monitoring: 13th – 20th August

New blood test can predict death or disability in patients within 24 hours of head injury A simple blood test using a sample taken within 24 hours of a severe brain injury can ascertain the likelihood that a patient will survive or not, a new study has discovered Researchers discovered that there was a correlation between levels of GFAP and…
Natalie Creaney
August 19, 2022
HighlightsHighlights Archive

NIHR Quarterly Update Summary

It has been yet another busy year for the NIHR and, as the summer draws to a close, now is the perfect time to examine the significant events involving the organisation over recent months. Perhaps most notable of all is the appointment of Dr Gail Marzetti as Director of the Science, Research and Evidence directorate at DHSC, replacing the esteemed…
Natalie Creaney
August 19, 2022
HighlightsHighlights Archive

Government seeks consultations with EU on science programmes as dispute escalates

The Government has officially begun formal consultations with the EU, with the intention of finalising the UK’s entry into EU science and research programmes, namely Horizon Europe, Euratom and Copernicus. The UK has been left infuriated by the EU’s refusal to sign off their access, caused by ongoing disputes over the Northern Ireland Protocol, and this move signals a clear…
Natalie Creaney
August 19, 2022
Membership NewsMembership News Archive

“Real World Health Economics” Online Event

“’Real World Health Economics’ - Getting the evidence of your solution to stakeholders-facilitating improved outcomes for end-users and efficient healthcare resource allocation” takes place at 9:30-12:30 Monday 19th September. This virtual event via Microsoft Teams is hosted by NIHR Cardiovascular MedTech Co-operative (King’s College London) and NIHR London In Vitro Diagnostics Co-operative (Imperial College London). The agenda for the event…
Natalie Creaney
August 19, 2022
Membership NewsMembership News Archive

Call for evidence: views being sought to tackle inequality in medical devices

The Independent Review on Equity in Medical Devices has launched a call for evidence to gather insights from experts and organisations, as well as patients and the general public, on the potential racial and gender bias of medical devices. The consultation seeks to understand whether medical devices and technologies are biased against patients of different ethnicities, genders and other socio-demographic…
Natalie Creaney
August 19, 2022
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