Factors influencing coverage decisions on medical devices: A retrospective analysis of 78 medical device appraisals for the Austrian hospital benefit catalogue 2008⿿2015

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.

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

Primary Dental Journal ◽

10.1177/2050168420980980 ◽

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.

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The Bioengineering Design Forum

Industry and Higher Education ◽

10.1177/095042229701100209 ◽

1997 ◽

Vol 11 (2) ◽

pp. 116-119 ◽

Cited By ~ 1

Author(s):

Patrick J. Prendergast

Keyword(s):

Medical Device ◽

Medical Devices ◽

Medical Device Industry ◽

Industry Collaboration ◽

University Industry ◽

Device Industry

The author assesses the results of the Bioengineering Design Forum – a collaboration between university researchers, clinicians and industry in Ireland. The aim of the Forum is to initiate, develop and bring to a successful conclusion R&D collaborations that lead to new or improved medical devices. By laying down certain operating procedures for the Forum, an effective ‘meeting ground’ has been developed which serves the objectives of both university engineering departments and the medical device industry in a unique way. The purpose of this paper is to relate our experiences of the Forum; they may be useful to others who would like to attempt similar initiatives in other fields. The author also describes the results that may be expected from this kind of university–industry collaboration in practice.

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

Asian Journal of Pharmaceutical Research ◽

10.52711/2231-5691.2021.00032 ◽

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.

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Medical Device Integration Model Based on the Internet of Things

The Open Biomedical Engineering Journal ◽

10.2174/1874120701509010256 ◽

2015 ◽

Vol 9 (1) ◽

pp. 256-261 ◽

Cited By ~ 3

Author(s):

Aiyu Hao ◽

Ling Wang

Keyword(s):

Information System ◽

Internet Of Things ◽

Medical Device ◽

Medical Devices ◽

Medical Information ◽

Medical Information System ◽

The Internet ◽

Model Based ◽

Device Integration ◽

The Internet Of Things

At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices lack mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical devices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop toward mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching between the data and the inspection with the terminal device in a timely manner.

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PP096 European Union-Health Technology Assessments For Medical Devices - How To Overcome Reimbursement Divergence

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317002616 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 116-117

Author(s):

Jana Hemmerling ◽

Karolin Eberle ◽

Sara Hogger ◽

Maike Gupta ◽

Anna Ullraum ◽

...

Keyword(s):

Health Care ◽

Medical Device ◽

Medical Devices ◽

Small Body ◽

Health Technology ◽

Surrogate Endpoints ◽

European Network ◽

Gemeinsamer Bundesausschuss ◽

Real World Data ◽

Clinical Reality

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

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