FINAL CALL! Dr Jane Freeman, Associate Professor in Clinical Microbiology, Leeds Institute for Medical Research, University of Leeds Clinical Scientist, Leeds Teaching Hospitals & National Clinical Lead for AMR Diagnostics and Rob Annan, Programme & Science Policy Lead for Anti-Microbial Resistance (AMR) Diagnostics for NHS England, would love for BIVDA members who have not already indicated their interest in this…
Ben KempSeptember 15, 2023
Members of the working party may be interested in the UK-China Intellectual Property Newsletter, which is released monthly by the FCO. The newsletter covers recent intellectual property (IP) developments in China. You can find the newsletter here.
Ben KempSeptember 15, 2023
Doris-Ann Williams has retired from her role as Chief Executive at BIVDA, after almost 22 years. Doris-Ann said, “I have been privileged to do a job I have loved representing the industry I am passionate about. It has been wonderful to see the value of diagnostics and laboratory medicine increase in profile in UK healthcare during the last 20 years,…
Ben KempSeptember 8, 2023
DHSC is working with a variety of key stakeholders to develop the 2024-2029 AMR National Action Plan for 2024 publication. The draft proposal contains outcomes and commitment which underpin the high-level objectives which are then intended to be supported by deliverables and actions in more granular detail. Any comments from stakeholders are being incorporated where appropriate to get expert input…
Ben KempSeptember 8, 2023
Comment period start date: 16/08/2023 Comment period end date: 03/10/2023 Scope This document provides guidance for applying an ISO 14971 risk management process when evaluating medical technology utilizing machine learning (ML). It is intended to apply to ML-enabled medical devices throughout all phases of the product lifecycle. This document is intended to be used in conjunction with ISO 14971. It…
Ben KempSeptember 8, 2023
Comment period start date: 16/08/2023 Comment period end date: 03/10/2023 Scope This document defines a standardized performance evaluation process for Machine Learning-enabled Medical Devices (MLMD). The set of processes, activities, and tasks described in this document establishes a common framework for MLMD performance evaluation. Purpose The evaluation of ML performance is a crucial factor in measuring the overall MLMD’s performance.…
Ben KempSeptember 8, 2023
Comment period start date: 17/08/2023 Comment period end date: 04/10/2023 Scope In addition to the requirements of IEC 61326-1, this part of IEC 61326 specifies the EMC test requirements for process automation equipment using at least one Ethernet-APL (Ethernet Advanced Physical Layer) compliant port. The type of equipment covered by this part includes infrastructure devices such as switches as well…
Ben KempSeptember 8, 2023
Comment period start date: 04/08/2023 Comment period end date: 11/09/2023 Scope This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart…
Ben KempSeptember 8, 2023
Comment period start date: 04/08/2023 Comment period end date: 11/09/2023 Scope This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices,…
Ben KempSeptember 8, 2023