Introduction Once a medical device is placed on the market, post-market surveillance (PMS) becomes crucial for identifying any unforeseen issues or risks that may not have been detected during the development phase. This article provides a comparative analysis of PMS…
Introduction A medical device ‘shall be safe and effective, […] taking into account the generally acknowledged state of the art’1: in other words, safety and efficacy are essential to a medical device. Safety, according to Regulation (EU) 2017/745 on medical…
Joint Working Group 1 (JWG1) of ISO/TC 210 and IEC/SC 62A is currently working on a revision1 of ISO 14971:2007 and its companion technical report ISO/TR 24971:2013, which are concerned with the application of risk management to medical devices. As for…
A first amendment has been drafted1,2 for ISO 10993-18:2020, Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process. This proposed amendment is undergoing voting in the ballot stage until 8…
A new standard, QFIS 001:2021, has been developed to identify and define requirements to ensure a medical device functions safely, and that the safety properties and characteristics of the device do not deleteriously affect its function resulting in an inferior…
In a collaboration between the British Standards Institution (BSI) and the Association for the Advancement of Medical Instrumentation (AAMI), a guidance document has been drafted on the application of ISO 14971 to artificial intelligence (AI) and machine learning (ML)1. The…
The Therapeutic Goods Administration (TGA) has published its expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigation strategies for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for Chlamydia trachomatis (chlamydia)1, Neisseria…
Introduction According to Title 21 of the Code of Federal Regulations (21 CFR) §801.5, reprocessing instructions are considered part of a device’s instructions for use1. This regulation supports the language of the law in section 502(f) of the Federal Food,…
ISO/TR 24971:2020, Medical devices – Guidance on the application of ISO 14971, was published in June 20201 to provide updated guidance on the development, implementation and maintenance of a risk management system for medical devices, including in vitro diagnostic medical…
On 23 December 2019, the Food and Drug Administration (FDA) updated its Recognized Consensus Standards database1. In total, 102 standards were added, including ISO 14971:2019, Medical devices – Application of risk management to medical devices. Reference 1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
In December 2019, ISO 14971:2019, Medical devices – Application of risk management to medical devices, was published1. This standard specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro…
The Draft International Standard (DIS) of the newly-revised ISO 14971, Medical devices – Application of risk management to medical devices, was circulated to the national standards’ organisations in July 2018 for comment1,2. At the same time, the latest Working Draft…
The Association for the Advancement of Medical Instrumentation (AAMI) has published a new Technical Information Report (TIR) entitled, Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems (TIR 69)1. This TIR applies to medical devices and systems (also…
New editions of ISO 14971, Medical devices – Application of risk management to medical devices1 and its companion document ISO/TR 24971, Medical devices – Guidance on the application of ISO 149712 are being prepared by a Joint Working Group from…
The international standard ISO 14971:2007 and its companion guidance ISO TR 24971:2013 are currently undergoing revision and the draft updates have been issued for comment and ballot by the national standards’ committees1,2. The two revised documents are: ISO/CD 14971, Medical…
Health Canada has informed stakeholders, notably manufacturers and importers of medical devices, that it intends to propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada1. These proposed changes to the Medical Devices Regulations…
