Highlights

Yesterday’s “in-Person” Mid-Year General Meeting was a fantastic event, we have had some great feedback and it was refreshing to see people face to face. It was a smaller affair than previous meetings, but as we take tentative steps, it is understandable and acceptable to be flexible as we emerge from the pandemic, it was more intimate than usual and…

MHRA Consultation – https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom  This remains open until 25 November and is a huge document with nearly 500 questions – not all will be relevant to IVDs but we need as many companies to respond as possible. You do not have to complete all the questions and even if you just respond to a few then this will increase the…

The Government has published its net zero strategy as part of its obligation to report to Parliament under the Climate Change Act 2008. This important paper sets out the vision for a decarbonised economy by 2050 two weeks ahead of the COP26 summit in Scotland. According to the document, if we fail to limit global warming to 1.5°C above pre-industrial…

The Defence and Security Accelerator (DASA) has launched a new challenge on Next Generation Wearable Technology - IFA03). Please find information from DASA below: We wish to understand what metrics can be collected from wearable technology platforms that are of credible value to the defence user community (i.e. the metrics are sufficiently robust that they can reliably and confidently inform…

The Department for Digital, Culture, Media and Sport (DCMS), along with the Office for Artificial Intelligence (AI) and Digital Standards and Internet Governance (DSIG), are leading a research project into how Research and Development (R&D) for AI is commercialised and brought to market. Oxford Insights and Cambridge Econometrics are the research consultants that have been commissioned to explore “the ways…

The British In Vitro Diagnostics Association is calling for this Spending Review to invest in key enablers to support the UK diagnostic sector’s capacity to tackle care backlogs, drive innovation and prepare for potential future pandemics. Building a diagnostics sector that is pandemic-ready and can protect the UK’s healthcare needs requires stronger UK manufacturing, innovation, a highly skilled workforce and…

The UK and New Zealand have agreed in principle on the terms of a new free trade agreement (FTA) this week. This move forms part of the United Kingdom’s push to link with countries in the Asia-Pacific region, and to expand bilateral relations across the globe after the UK’s departure from the EU. The deal was agreed to in principle…

The European Commission has published a proposal for progressive transitional arrangements for the new IVD Regulation. It is proposing to extend the transition period for higher risk diagnostics, such as HIV or hepatitis tests (class D) and certain influenza tests (class C), until May 2025 and May 2026 respectively, whilst lower risk products in classes B and A would have…

There will be a virtual event hosted by KTN/ABPI/Innovate UK on 'Net Zero in Medicines Manufacturing: Measuring and Reporting Carbon Footprint'. It takes place on Friday 22 October from 10am-12pm. This free to attend webinar is aimed at medicines manufacturers to learn about systems and tools for measuring and reporting on Scope 1, 2 and 3 carbon outputs.  Manufacturers of…

The MHRA's Sally Mounter has said that they are considering a new Agency wide vigilance reporting system. A workshop for device manufacturers will be held on 21st October between 1:30 and 3:30 to find out more about their experiences with vigilance reporting to date. You can register your interesting in attending the workshop at civs@mhra.gov.uk