| Medicines and Healthcare products Regulatory Agency (MHRA) |
Responsible for ensuring the safety, quality and effectiveness of medicines, medical devices and blood components for transfusion in the UK |
Recommendations on Human Factors and usability engineering during medical device development. Recommend submission of a Human Factors summary report and post-market surveillance for human factors and ergonomic issues [7].
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| International Organisation for Standardisation (ISO) |
Develop and publish international standards. |
ISO 14971 [8] relates to the application of risk management of medical devices and is the overarching standard to employ in developing safe and effective devices and, as such, infers an expectation to assess safe usability through the application of related usability standards. The current 2019 3rd edition, increases emphasis on defining the benefit and state- of-the-art of the device as it relates to residual risk, introduced a new definition of “reasonably foreseeable misuse” – (emphasizing the context of such use in assessing whether it can be used safely)- and increased focus on gathering post-market user feedback
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| International Electro-technical Commission (IEC) |
Prepares and publishes international standards for all electrical, electronic and related technologies |
IEC (or BS EN) 62366 specifies a process by which a manufacturer can analyse, specify, develop and evaluate the usability of a medical device to ensure safety and mitigate risks associated with correct use, and use errors, within the scope of normal use [9,10]. IEC (or BS EN) 62304 defines the “life cycle requirements” for medical device software and describes a set of processes, activities, and tasks to establish common framework for medical device software life cycle processes, when software is itself a medical device, or when software is an embedded or integral part of the final medical device [11]. IEC (or BS EN) 60601 refers a family of standards relating to the medical electrical equipment. Part 1 (60601-1) relates to the basic safety and essential performance for all medical electrical equipment. Part of the same family, IEC (or BS EN) 60601-1-6 is an updated collateral standard specifically intended to support the usability of medical electrical equipment. [12] Considering the context of usage, the collateral standard IEC 60601-1-11:2015 (or BS EN BS EN 60601-1-11:2015 + A1: 2021 for those in the UK/EU) considers the basic safety of medical electrical equipment when used in the home environment [13].
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| European Commission |
The European regulatory framework ensures the safety and efficacy of medical devices and facilitates patient access to devices in the European market. |
The EU Medical Device Regulation (2017/745) [14] increased focus on usability compared to the former EU Medical Device Directive (93/42/EEC) in recognition of safety issues arising related to usability and an increasing shift to more lay-user managed medical devices [15]. There is an emphasis on specifying the users of a device, and ensuring that the human factors issues that influence use and interactions are fully understood. It aims to ensure the medical device is designed with the end-users and that their cognitive and physical capabilities and limitations are understood and taken into account through the design.
N.B. MHRA consultation on the future requirements for UKCA marking following the UK’s exit from the EU is underway.
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| American National Standards Institute (ANSI) |
Promote and facilitate voluntary consensus standards and conformity assessment systems to enhance US global business competitiveness and US quality of life. |
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