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.

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

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.

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.

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

2019 ◽  
pp. 216847901987073 ◽  
Author(s):  
Beata Wilkinson ◽  
Robert van Boxtel
Keyword(s):  
European Union ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Real World ◽  
The European Union ◽  
Clinical Investigations ◽  
Clinical Benefits ◽  
The Eu ◽  
Medical Device Regulation

This article comments on the new approach to the clinical evaluation of medical devices in the European Union (EU), which adds consideration of intended clinical benefits to the traditional focus on safety and performance. The article also discusses types of clinical benefits that may be claimed and how evidence for them may be generated. In the EU, determining the benefit-risk profile is an existing core requirement of the clinical evaluation performed according to MEDDEV 2.7/1 Rev 4 guidelines, but under the new Medical Device Regulation (MDR), “intended” clinical benefits must be determined first. The MDR sets high standards for ensuring reliable data are generated from clinical investigations. It stipulates that the endpoints of clinical investigations should include clinical benefits. However, many clinical-use questions arise only after a device is made widely available to patients. For all medical devices, particularly for on-the-market devices never subjected to randomized controlled trials and for new devices developed when these trials were inappropriate/impossible, the postmarket phase of the device is a valuable source of clinical-benefit data. Postmarket clinical follow-up can corroborate and refine predictions of clinical benefits over time. Indirect clinical effects, which may affect treatment adherence and influence patients’ well-being, may surface in the postmarket phase. Real-world clinical data will improve the manufacturer’s understanding of their device’s clinical benefits, potentially changing claims of intended clinical benefits in subsequent clinical evaluations. A paradigm change in clinical evaluation of medical devices in the EU will ensue when manufacturers ensure that their devices deliver real-world clinical benefits.

scholarly journals Medical Device Regulation from a Health Service Provider’s Perspective

Prosthesis ◽  
2021 ◽  
Vol 3 (3) ◽  
pp. 261-266
Author(s):  
Man Ting Kwong ◽  
David Stell ◽  
Emmanuel Akinluyi
Keyword(s):  
Health Service ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Setting ◽  
Service Providers ◽  
Healthcare Providers ◽  
Current Trends ◽  
Health Service Providers ◽  
The Uk ◽  
Medical Device Regulation

Unfamiliarity with medical device regulations can sometimes be a barrier to deploying technology in a clinical setting for researchers and innovators. Health service providers recognise that innovation can happen within smaller organisations, where regulatory support may be limited. This article sets out to increase transparency and outline key considerations on medical device regulations from a UK healthcare provider’s perspective. The framework used by Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) for assessing research devices is presented to give an overview of the routes that R&D medical devices take to enter a clinical setting. Furthermore, current trends on research studies involving medical devices were extracted from the GSTFT internal R&D database and presented as the following categories (i) commercial vs. non-commercial, (ii) assessment type and (iii) software vs. non-software. New medical devices legislation will be introduced within the UK in July 2023. It is anticipated regulating software as a medical device may become more challenging for healthcare providers and device manufacturers alike. It is therefore important for different stakeholders involved to work together to ensure this does not become a barrier to innovation.

scholarly journals EU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?

2021 ◽  
Vol 9 (4) ◽  
pp. 33-36
Author(s):  
Vidya Sagar ◽  
Piyush Patel ◽  
Avni Rana ◽  
Bhavin Trivedi ◽  
Deepak Patel ◽  
...  
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Management Plan ◽  
European Database ◽  
Periodic Safety ◽  
Post Market ◽  
Periodic Safety Update Report ◽  
Medical Device Regulation

Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I. Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices. A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.

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