Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation

2021 ◽  
pp. 1-18
Author(s):  
Sofia Palmieri ◽  
Paulien Walraet ◽  
Tom Goffin
Keyword(s):  
Artificial Intelligence ◽  
European Commission ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Field ◽  
Medical Device Manufacturers ◽  
Regulatory Landscape ◽  
Medical Device Regulation ◽  
Regulatory Intervention

Abstract In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.

scholarly journals Malaysian Medical Device Regulation for Artificial Intelligence in Healthcare: Have all the pieces fallen into position?

2021 ◽  
Vol 6 (16) ◽  
pp. 137-144
Author(s):  
Nurus Sakinatul Fikriah Mohd Shith Putera ◽  
Sarah Munirah Abdullah ◽  
Noraiza Abdul Rahman ◽  
Rafizah Abu Hassan ◽  
Hartini Saripan ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Medical Device ◽  
Medical Devices ◽  
Publishing House ◽  
Legal Reasoning ◽  
Healthcare Applications ◽  
Artificial Intelligence And Law ◽  
Learning And Adaptation ◽  
Research Findings ◽  
Medical Device Regulation

Artificial Intelligence (AI) ability of self-learning and adaptation has challenged the medical device regulation in overseeing the safety and effectiveness of medical devices. Thus, this research aims to evaluate the adequacy of the pre-market requirements under the Medical Device Act 2012 in governing AI modification. Employing the doctrinal research methodology, systematic means of legal reasoning pertinent to AI for healthcare applications are produced. An effective medical device regulation is pivotal to foster trustworthiness in the governance and adoption of AI. However, the research findings indicate the deficiency of the current conformity assessment for medical devices in addressing AI modifications. Keywords: Artificial Intelligence and Law, Artificial Intelligence and Medical Device Regulation, Malaysian Medical Device Regulation eISSN: 2398-4287© 2021. The Authors. Published for AMER ABRA cE-Bs by e-International Publishing House, Ltd., UK. This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Peer–review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians/Africans/Arabians) and cE-Bs (Centre for Environment-Behaviour Studies), Faculty of Architecture, Planning & Surveying, Universiti Teknologi MARA, Malaysia. DOI: https://doi.org/10.21834/ebpj.v6i16.2635

scholarly journals Medical Devices: Regulation, Risk Classification, and Open Innovation

2020 ◽  
Vol 6 (2) ◽  
pp. 42 ◽  
Author(s):  
Lukas Peter ◽  
Ladislav Hajek ◽  
Petra Maresova ◽  
Martin Augustynek ◽  
Marek Penhaker
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Social Structures ◽  
Added Value ◽  
Strategic Decisions ◽  
The Czech Republic ◽  
Risk Class ◽  
Medical Device Manufacturers ◽  
Legislative Changes ◽  
Medical Device Regulation

In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly.

Digital health – Software as a medical device in focus of the medical device regulation (MDR)

2019 ◽  
Vol 61 (5-6) ◽  
pp. 211-218
Author(s):  
Kurt Becker ◽  
Myriam Lipprandt ◽  
Rainer Röhrig ◽  
Thomas Neumuth
Keyword(s):  
Artificial Intelligence ◽  
Medical Device ◽  
Medical Devices ◽  
Digital Health ◽  
Legal Framework ◽  
Policy Framework ◽  
Medical Software ◽  
Approval Procedure ◽  
Health Applications ◽  
Medical Device Regulation

Abstract The Medical Device Directive (MDD) will be replaced on 26.05.2020 by the new Medical Device Regulation (MDR). The European Parliament wants to create a transparent, solid, predictable and sustainable legal framework. One of the major upcoming changes effects the perspective on software as a medical device. This paper describes the fundamental relationships between the policy framework and the challenges faced by manufacturers and operators of medical devices, in particular medical software and artificial intelligence (AI) systems, who need to verify compliance. To address this topic, we review and discuss the main implications of medical device regulations on software as a medical device and digital health applications along the MDR structure. Furthermore, we address practical limitations of the implementation, such as the availability of notified bodies and costs of the approval procedure.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

Medical device’s regulation in South-East Asian countries: Current status and gap areas

2021 ◽  
pp. 173-179
Author(s):  
Vivekanandan Kalaiselvan ◽  
Aishwarya G. ◽  
Ashish Sharma
Keyword(s):  
Adverse Event ◽  
Medical Device ◽  
Medical Devices ◽  
East Asian ◽  
Time Frame ◽  
Adverse Event Reporting ◽  
World Health ◽  
Current Status ◽  
Event Reporting ◽  
Medical Device Regulation

As Medical device application in disease prevention, diagnosis or treatment is evolving to a greater extent; there is a need for regulation to monitor its quality, safety and efficacy. The present article attempts to study the medical device regulation available in eleven South-East Asian World Health Organization (WHO) member countries. The information searched from the available sources reveals that medical device regulation exists in seven countries. Most of the countries follow the International Organization for Standardization (ISO) 13485 for their quality standards in medical devices. Most countries also specified the time frame and authority to which adverse event is to be reported. Countries like India and Thailand have separate Adverse Event reporting forms for the medical device. The present study reveals that there is no separate web-based database for adverse event reporting of medical devices. Therefore, WHO South-East Asian Regulators Network (SEARN) under South East Regulatory Office (SERO) office may provide handholding support to these regions in developing a common software or tool for the management and analysis of signals arising from the adverse events.

A Platform and Multi-sided Market for Translational, Software-defined Medical Research in the Operation Room: OP 4.1 (Preprint)

2021 ◽  
Author(s):  
Magdalena Görtz ◽  
Michael Byczkowski ◽  
Mathias Rath ◽  
Viktoria Schütz ◽  
Philipp Reimold ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Heterogeneous Data ◽  
Healthcare Sector ◽  
Successful Development ◽  
Software Developers ◽  
Intelligent Support ◽  
Operation Room ◽  
Central Platform ◽  
Medical Device Manufacturers

BACKGROUND While digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart, connected devices in healthcare is still in its beginnings. Innovative solutions for the medical environment suffer from difficult access to medical device data and high barriers for market entry due to proprietary systems. OBJECTIVE In the proof-of-concept project OP 4.1, we show the business viability of connecting and augmenting medical devices and data through software add-ons by giving companies a technical and commercial platform for the development, implementation, distribution, and billing of innovative software solutions. METHODS The creation of a central platform prototype requires the collaboration of several independent market contenders, amongst them medical users, software developers, medical device manufacturers, and platform providers. A dedicated consortium of clinical and scientific partners as well as industry partners was established. RESULTS We demonstrate the successful development of the prototype of a user-centric, open, and extensible platform for the intelligent support of processes starting with the operation room. By connecting heterogeneous data sources and medical devices from different manufacturers and making them accessible for software developers and medical users, the cloud-based platform OP 4.1 enables the augmentation of medical devices and procedures through software-based solutions. The platform also allows for the demand-oriented billing of applications and medical devices, thus permitting software-based solutions to fast-track their economic development and become commercially successful. CONCLUSIONS The technology and business platform OP 4.1 creates a multi-sided market for the successful development, implementation, distribution, and billing of new software solutions in the operation room and in the healthcare sector in general. Consequently, software-based medical innovation can be translated into clinical routine fast, efficiently, and cost-effectively, optimizing the treatment of patients through smartly assisted procedures.

Adopting Identification Standards in the Medical Device Supply Chain

2020 ◽  
Vol 13 (1) ◽  
pp. 1-14 ◽  
Author(s):  
Yousef Abdulsalam ◽  
Dari Alhuwail ◽  
Eugene S. Schneller
Keyword(s):  
Supply Chain ◽  
Medical Device ◽  
Medical Devices ◽  
Business Intelligence ◽  
Return On Investment ◽  
Survey Methods ◽  
Device Identification ◽  
Medical Device Manufacturers ◽  
High Level ◽  
The U.S

The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.

scholarly journals Application of Artificial Intelligence Technology in Oncology: Towards the Establishment of Precision Medicine

Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3532 ◽  
Author(s):  
Ryuji Hamamoto ◽  
Kruthi Suvarna ◽  
Masayoshi Yamada ◽  
Kazuma Kobayashi ◽  
Norio Shinkai ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Precision Medicine ◽  
Medical Devices ◽  
The United States ◽  
Medical Data ◽  
Clinical Implementation ◽  
Medical Field ◽  
Core Technology ◽  
Artificial Intelligence Technology ◽  
History Of

In recent years, advances in artificial intelligence (AI) technology have led to the rapid clinical implementation of devices with AI technology in the medical field. More than 60 AI-equipped medical devices have already been approved by the Food and Drug Administration (FDA) in the United States, and the active introduction of AI technology is considered to be an inevitable trend in the future of medicine. In the field of oncology, clinical applications of medical devices using AI technology are already underway, mainly in radiology, and AI technology is expected to be positioned as an important core technology. In particular, “precision medicine,” a medical treatment that selects the most appropriate treatment for each patient based on a vast amount of medical data such as genome information, has become a worldwide trend; AI technology is expected to be utilized in the process of extracting truly useful information from a large amount of medical data and applying it to diagnosis and treatment. In this review, we would like to introduce the history of AI technology and the current state of medical AI, especially in the oncology field, as well as discuss the possibilities and challenges of AI technology in the medical field.

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