An update from EMA on guidance especially for companion diagnostics. Note that this EU guidance also impacts Northern Ireland as it continues to follow the EU IVD Regulation. The document can be found here.
Ben KempFebruary 17, 2025
Please note that the European Commission has launched a dedicated website for clinical investigations and performance studies coordinated assessment pilot: Medical Devices - Clinical investigations and performance studies - European Commission and with this also officially opened the call for expression of interest for the Clinical Investigations (MD) pilot: Pilot coordinated assessment for CI/PS - European Commission For medical devices:…
Ben KempFebruary 14, 2025
The EU have opened their Coordinated assessment for clinical investigations: a call for expression of interest webpage.
Ben KempFebruary 14, 2025
This document provides guidance to manufacturers who are submitting a new or amendment application for Class II, III and IV MLMD under the regulations.
Ben KempFebruary 14, 2025
BIVDA is excited to announce a new partnership with MedBoard, an innovative cloud platform that centralises global medical, MedTech, Digital Health, and Pharma information. MedBoard empowers professionals, teams, and organisations with accessible, cutting-edge digital tools to enhance their work and decision-making. As part of this collaboration, BIVDA members can enjoy exclusive discounts on their first-year MedBoard subscription – a…
Ben KempFebruary 12, 2025
The International Congress of Paediatric Laboratory Medicine (ICPLM) is to be held on Sunday May 18, 2025, in Brussels, as a Satellite to the main XXVI IFCC-EFLM EuroMedLab 2025. This special conference is being organized by the IFCC Committee on Emerging Technologies in Paediatric Laboratory Medicine (C-ETPLM) with the support of the IFCC Congresses and Conferences Committee as well as…
Ben KempFebruary 7, 2025
The European Commission has launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device. They also enable HTDs to obtain guidance on the information, data, analyses, and…
Ben KempFebruary 7, 2025
International AI Safety Report 2025 Page summary: A report on the state of advanced AI capabilities and risks – written by 100 AI experts including representatives nominated by 33 countries and intergovernmental organisations. Change made: First published. Time updated: 1:16pm, 29 January 2025 First International AI Safety Report to inform discussions at AI Action Summit Page summary: First Independent International…
Ben KempFebruary 7, 2025
NHS England annual accountability statement: 2022 to 2023 Page summary: NHS England’s performance measured against the NHS public health functions agreement for 2022 to 2023. Change made: First published. Time updated: 11:04am, 27 January 2025 NHS England annual accountability statements Page summary: NHS England’s performance measured against the NHS public health functions agreement. Change made: First published. Time updated: 11:06am,…
Ben KempFebruary 7, 2025
UK MOUs with US states on economic cooperation and trade relations Page summary: Find out about the memoranda of understanding (MOUs) on cooperation and trade relations the UK has signed with US states. Change made: UK and Colorado trade and economic co-operation memorandum of understanding added to collection. Time updated: 11:59pm, 27 January 2025 UK and Colorado trade and economic…
Ben KempFebruary 7, 2025