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NEWS
The Independent Monitoring Board (IMB) has reported increased throughput, violence and self-harm at Yarl’s Wood Immigration Removal Centre (IRC) in 2025, together with continuing concerns about the detention of vulnerable people. Its principal concerns include indeterminate detention, routine handcuffing for hospital visits, failures in transferring medical records, delays in psychiatric transfers and slow case progression.
NEWS
The Independent Monitoring Boards (IMB) have published a thematic report highlighting concerns that the use of force in immigration detention has become routine, inconsistent, and frequently unjustified, straying from the principles of necessity, proportionality, and respect for the dignity of those detained. The report highlights widespread issues, including the habitual and unwarranted use of handcuffs, the failure to uphold the presumption against restraint and the application of force without proper risk assessments. It also notes that force is often used inconsistently, driven by contractor preferences rather than individualised assessments, with staff regularly missing opportunities to de-escalate situations, particularly when language barriers or mental health needs are overlooked.
NEWS
The International Medical Device Regulators Forum (IMDRF) has opened a consultation on guiding principles for artificial intelligence/good machine learning (AI/ML) practices in medical device development. These are identical to a 2021 document published by US, UK, and Canadian regulators. These principles include ensuring the device's intended use and purpose are well understood and that a range of experts are involved during the product's lifespan to evaluate it, all of which are part of the guiding principles developed by US, UK, and Canadian regulators. Another important principle in the guiding principles document is that the device performance should consider how it will be used in the clinical setting, or how the human-artificial intelligence team will likely use the product in its intended use environment. It adds that human factors such as normal user skills, user expertise, user understanding of the model outputs and limitations, and user error should be considered. The consultation closes on 30 August 2024.
NEWS
The International Medical Device Regulators Forum (IMDRF) has opened a public consultation on a draft technical framework for artificial intelligence life cycle management in medical devices, running from 10 April 2026 to 10 July 2026. The framework builds on IMDRF’s 2025 Good Machine Learning Practice principles and provides internationally harmonised concepts covering the full life cycle from planning and design to decommissioning. It addresses universal concepts including quality management, risk management, human oversight and cybersecurity, alongside considerations for data collection, model building, verification and validation, deployment and monitoring.
NEWS
The International Medical Device Regulators Forum (IMDRF) has published two final documents: the Playbook for Medical Device Regulatory Reliance Programs IMDRF GRRP WG N89 FINAL 2026 and Considerations for the Selection of IMDRF Adverse Event Terminology IMDRF AET WG N86 FINAL 2026. The reliance playbook, developed by the Good Regulatory Review Practices Working Group, provides structured guidance for regulatory authorities on establishing and operating reliance programmes for medical devices, including in vitro diagnostics. It explains how regulators may give significant weight to assessments or decisions of trusted reference authorities while retaining responsibility for final decisions. The document outlines three principal models, namely work sharing, abridged regulatory pathways and recognition, and sets out practical steps for implementation, including assessing legal frameworks, defining scope and eligibility, engaging stakeholders, formalising processes and agreements, and establishing oversight and performance monitoring systems to ensure effective and proportionate use of reliance.
NEWS
The International Medical Device Regulators Forum (IMDRF) has published its final technical guidance document, which applies specifically to changes to medical device software and outlines essential principles and content for predetermined change control plans (PCCPs). The guidance document aims to facilitate international convergence on PCCPs without replacing existing national laws or regulations. A PCCP offers an alternative to submitting a new or supplementary regulatory application for each planned change to marketed medical device software. Instead, manufacturers can obtain advance authorisation for a series of predetermined changes as part of an initial or existing submission. Once these changes are mutually agreed upon by manufacturers and regulators and remain within the device's original intended use, separate submissions for each change are not required.
NEWS
The International Medical Device Regulators Forum (IMDRF) has published its strategic plan for 2026–2030, outlining measures to accelerate global regulatory convergence for medical devices and strengthen governance. The plan sets out five strategic focus areas: (1) modernising governance to support sustainable and transparent growth; (2) reinforcing foundational regulatory principles by converting legacy Global Harmonization Task Force (GHTF) documents into updated IMDRF guidance; (3) addressing regulatory challenges posed by innovative technologies through the development of new technical documents and joint workshops with the IMDRF Industry Group; (4) expanding stakeholder engagement through new and enhanced mechanisms for participation and outreach; and (5) strengthening support for the implementation of IMDRF documents through training and practical guidance. To support consistent application across jurisdictions, the plan also calls for a more systematic and structured approach to IMDRF training programmes. The plan builds on progress made during the 2021–2025 strategic period, which was marked by rapid technological innovation, increased use of regulatory reliance mechanisms and significant regulatory disruption arising from the coronavirus (COVID-19) pandemic. During this time, regulators faced accelerating technological developments, including artificial intelligence (AI), machine learning (ML) and digital therapeutics, while adapting regulatory systems to pandemic-related pressures. IMDRF responded by issuing guidance on personalised medical devices, Software as a Medical Device (SaMD), AI-enabled medical devices and cybersecurity, and by developing the Reliance Playbook to promote more efficient and coordinated regulatory cooperation.
NEWS
The International Medical Device Regulators Forum (IMDRF) has released two guidance documents: one on guiding principles for good machine learning practices (GMLPs) in medical device development and another on risk characterization for medical device software and software-specific risks.
NEWS
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices, including for in vitro diagnostics and combination products. The proposed guidance is open for comments until 6 July 2026. It recommends that manufacturers be familiar with International Organization for Standardization’s (ISO) 13485 which covers the quality management system (QMS) and ISO/Technical Committee’s (TC) 210 standard for practical guidance on implementing ISO 13485. All suppliers, whether internal or external, must be under the manufacturer’s control and are ultimately its responsibility even if third parties are involved. Manufacturers should carefully assess potential suppliers by evaluating their business and operational capabilities, including their technological competence, and must keep a formal record of its acceptance or approval of the supplier, signed by an authorised person. The guidance also provides examples of how the guidance can work in practice for a sterile product and a low-risk component of a medical device.
NEWS
The International Monetary Fund (IMF) has warned that reforms to the UK pension landscape aiming to unlock pension savings for higher-return investments should not undermine financial stability or pensioner outcomes. In its Concluding Statement following its mission to the UK, the IMF recognised the rationale for consolidating smaller pension funds but warned that these outcomes would take time and effort to realise and that caution is warranted around the implications to financial stability, particularly with regard to the ongoing defined benefit fund buy-outs.
NEWS
Law360: UK government plans to consolidate smaller pension funds into larger megafunds may reduce competition in the sector and would benefit from enhanced oversight by the retirement savings watchdog, the International Monetary Fund (IMF) said on 27 May 2025.
NEWS
Law360: Government plans to consolidate smaller pension funds into larger megafunds may reduce competition in the sector and would also benefit from enhanced oversight by the Pensions Regulator (TPR), the International Monetary Fund (IMF) said on 27 May 2025.