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ISO/PWI 24884 Electronic Instructions for Use for In Vitro Diagnostic Medical Devices (Minimum required information and means of delivery)

Scope The proposed new standard provides guidelines on the conditions (means of delivery) and minimum required information which shall be physically delivered, when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). Not in the scope of this standard: The content of the eIFU as it is covered by ISO 18113-1, -2, -3, -4, -5. This…
Dawn
December 1, 2023
ConsultationsConsultations Archive

ISO/PWI TS 24883 Lateral flow immunoassay for rapid diagnostic testing — General guideline for test performance

Scope This document provides the general principles and guideline for the rapid diagnostic testing (RDT) of LFIA used for the In vitro diagnostics as follows: — Design and development of LFIA — General guideline for test performance of LFIA — Recommendations for the use of LFIA This document is specific to the RDT of LFIA, which employ the gold nanoparticle…
Dawn
December 1, 2023
ConsultationsConsultations Archive

ICO consultation on the draft transparency in health and social care guidance

This consultation closes on 07 January 2024. You can access the all information here. The Information Commissioner’s Office (ICO) is producing guidance on transparency in the health and social care sector. The draft of this guidance is now published for public consultation. The draft transparency in health and social care guidance has been developed to help health and social care organsiations…
Dawn
November 17, 2023
ConsultationsConsultations Archive

Tumour profiling tests to guide adjuvant chemotherapy decisions in lymph node positive early breast cancer

NICE's diagnostics guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (DG34) makes recommendations on tumour profiling tests for oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative and lymph node (LN)-negative (including micrometastatic disease) early breast cancer. This guidance will assess use of the tests for ER-positive, HER2-negative cancer that has spread to the…
Dawn
November 17, 2023
ConsultationsConsultations Archive

Call for Evidence – National Security and Investment Act

Call for evidence description The Government will use this Call for Evidence to consider changes to the NSI regime. We are looking for views from cross economy stakeholders both in the UK and overseas. In particular, this evidence will help the Government: Hone the scope of the system’s mandatory notification requirements; Improve NSI notification and assessment processes; and Develop the…
Dawn
November 17, 2023
ConsultationsConsultations ArchiveExternal Affairs Working PartyExternal Affairs Working Party ArchiveInfectious Diseases Working PartyInfectious Diseases Working Party ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

NICE guideline on suspected sepsis – consultation

This NICE guideline covers suspected sepsis: recognition, diagnosis and early management – source control, rapid antigen tests, indicators of organ hypoperfusion, intravenous fluids, and vasopressors in the NEWS2 population. You can now comment on this draft scope. The scope defines what the guideline will (and will not) cover. The consultation closes at 5pm, Thursday 23 November 2023.
Dawn
November 10, 2023
ConsultationsConsultations Archive

ISO/PWI 24051-2 Medical laboratories — Part 2: Digital pathology and artificial intelligence (AI)-based image analysis

Deadline: 28 November Scope This document specifies requirements and gives recommendations for the digitalization of slidemounted, stained sections, processing of digital whole slide images, and artificial intelligence (AI) based image analysis to support anatomical pathology examination. This document focuses on sections from formalin-fixed paraffin-embedded (FFPE) tissues (derived e.g. from surgical resection, biopsy or autopsy). It is also applicable to paraffin-embedded…
Ben Kemp
November 2, 2023
ConsultationsConsultations Archive

ISO/PWI 24051-1 Medical laboratories — Part 1: General principles for the application of artificial intelligence in medical laboratories

Deadline: 28 November Scope This document specifies general principles for the application of artificial intelligence in the medical laboratory. This document is applicable to methods commonly considered subsets of artificial intelligence, including fuzzy logic, Bayesian networks, supervised and unsupervised machine learning, deep learning, neural networks, expert systems, robotics, natural language processing and image analysis.   Purpose Artificial intelligence refers to…
Ben Kemp
November 2, 2023
ConsultationsConsultations Archive

Health Protection (Notification) Regulations 2010: proposed amendments

  Consultation description This consultation seeks relevant stakeholder’s views on proposed additions to schedule 1 and 2 of the Health Protection (Notification) Regulations (HPNR) 2010 and amendments to diagnostic laboratory reporting requirements in England. The Department of Health and Social Care (DHSC) will publish a response to this consultation in due course. The HPNR (which apply to England only) place a statutory…
Dawn
October 27, 2023
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Medical Devices in Primary Care: Proposals for updating Part IX of the Drug Tariff – medical devices available for prescribing in primary care.

The government has today released the anticipated consultation on Medical Devices in Primary Care: Proposals for updating Part IX of the Drug Tariff – medical devices available for prescribing in primary care. Following the publication DHSC’s Medical Technology Strategy in February 2023, they have set out a series of proposals to modernise Part IX of the Drug Tariff to ensure…
Ben Kemp
October 6, 2023
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