British In Vitro Diagnostics Association (BIVDA)

In the current turbulent times, with the NHS under pressure, the most challenging political climate in living memory, and economic uncertainty, the role of BIVDA is more crucial to the success of the medical diagnostics sector than ever before. With that in mind, we have launched our 2024-2027 strategy to place diagnostics at the heart of healthcare - for all.

We look forward to welcoming members and invited guests to our Diagnostics: The State of the Nation parliamentary reception tomorrow. It promises to be an incredibly valuable event which will examine the current state of diagnostics in the UK and what can be done to remove barriers and grow the sector for the benefit of patients nationwide. We are fortunate to have an expert line-up of speakers from industry, NHSE and government, including Health Minister, Baroness Merron; Director of the OLS, Rosalind Campion; and the National Medical Director for Transformation at NHSE, Professor Erika Denton. We look forward to seeing everyone there!

Myself and Nancy Consterdine created IVDeology Ltd to provide a common sense approach to understanding and complying to the IVD regulations (hence the name). Part of this is imparting our knowledge to the next generation of Reg Affairs professionals. So it is an honour to be at the University of Birmingham medical school today in association with British In Vitro Diagnostics Association (BIVDA) to present a module on Medical Device Regulation. I have been impressed so far on understanding the key concepts on intended purpose and classification. 😀 #ivd #training #ukca

💡 BIVDA's Head of Policy, Programmes, and Compliance, Paul DF, has authored an article for the latest Chamber UK Journal. He examines how diagnostics balance their life-saving clinical support with ever-growing sustainability targets, arguing that the key is innovation, not legislation. Sign-up below to read! 👇

⏰ Reminder: the National Procurement Policy Statement consultation closes next Monday 4 November at Midday. The Procurement Act 2023 will now commence on 24 February 2025. This will allow time for a new National Procurement Policy Statement (NPPS) to be produced. Contributions to its development are being sought by government via this survey 👇 https://lnkd.in/eC95j8tE The NPPS will set out the Government’s strategic policy priorities for public procurement, and is an essential element of the Procurement Act. BIVDA’s procurement workstream is led by our Head of Market Access, Beth Loudon. We will respond to this survey on behalf of members, but please send your feedback individually to beth.loudon@bivda.org.uk for inclusion.

Amanda Maxwell opens day 2 #GlobalAccess2024 with a session on "Navigating the Horizontal Regulatory Matrix" with insights from Qserve Group Gert Bos, PhD, FRAPS, MedTech Europe Benjamin Meany, British In Vitro Diagnostics Association (BIVDA) Neil Plumridge, Teleflex David O’Flynn, and Axon Lawyers Erik Vollebregt. The panel explore the increasingly complex horizontal regulatory landscape from digital to environmental, along with strategies for seizing opportunities while avoiding challenges.

BIVDA have submitted response to the Medicines and Healthcare products Regulatory Agency fees consultation response before the deadline tomorrow. We would like to thank members for their very detailed submissions to date which has allowed us to develop a robust response which strongly challenges the proposed fees increase. Head of Programmes and Policy, Paul DF says: “We work closely with the MHRA and value our relationship with them. However, above all we have a duty to support members and the IVD industry. The MHRA fees proposal to charge by GMDN codes will see member fees rising by an average of 5,550%. The plans are flawed and I know have caused members a great deal of concern. "We have been in regular dialogue with the MHRA, including submitting an FOI request for their financial modelling. Our consultation response is a detailed rebuttal of their proposals. I’m optimistic that the MHRA will listen to reason and a more equitable model will follow.” BIVDA’s regulatory manager, Neil Plumridge would like to personally thank members: “Since we received the MHRA proposal, our members have submitted a large volume of evidence and financial modelling – no doubt a sign of the concern these proposals generated. This has made our response much more robust, and I’m genuinely grateful to all those who have supported this submission."

🏛 The BSI Meet the Experts: In Vitro Diagnostics Regulation event is taking place in Amsterdam on 27 November 2024. BIVDA members can get an exclusive 25% discount for the event. If you wish to receive the code, please email ben.kemp@bivda.org.uk. This IVDR focussed event has been designed for regulatory professionals, specialists and consultants from EU and UK who are navigating the complex landscape of IVDR. The event will provide a unique opportunity to interact in-person with the BSI team of IVDR experts to understand key topics, including the new transitions timelines, application process, QMS, EU AI Act and software will be covered throughout the event. You can sign-up and find out more here 👇 https://lnkd.in/erM69DXN

💡 BIVDA were delighted to host Curia's exclusive breakfast roundtable with Liberal Democrat Spokesperson for Hospitals and Primary Care, Jessica Brown-Fuller MP, at our offices this morning. Following their record-breaking success at the last election, the Liberal Democrats will be a key voice on health policy during this Parliament, as Labour outlines its proposals for significant NHS reform. We look forward to working with Ms Brown-Fuller and the wider Liberal Democrat health team as we advocate for improved utilisation of medical diagnostics in primary care to prevent ill health and improve patient outcomes.

MHRA Lay Post Market Surveillance (PMS) Statutory instrument Before Parliament. The MHRA yesterday laid their enhanced Post Market Surveillance requirements Statutory Instrument before parliament. This SI is one of three planned SI’s amending the UK MDR 2002, to make the legislation effective more than 20 years after its initial publication. Following BIVDA’s representations, there have been changes from the draft originally put before the WTO. Our regulatory team are reviewing the document and will provide further guidance to members in due course via our usual channels. https://lnkd.in/eAUySsGi