scholarly journals Medical Device Regulation Efforts for mHealth Apps during the COVID-19 Pandemic—An Experience Report of Corona Check and Corona Health

J ◽  
2021 ◽  
Vol 4 (2) ◽  
pp. 206-222
Author(s):  
Marc Holfelder ◽  
Lena Mulansky ◽  
Winfried Schlee ◽  
Harald Baumeister ◽  
Johannes Schobel ◽  
...  
Keyword(s):  
Medical Device ◽  
Development Process ◽  
Regulatory Requirements ◽  
Healthcare Environment ◽  
Medical App ◽  
Regulatory Guidelines ◽  
Enormous Amount ◽  
Software Engineers ◽  
Mhealth Apps ◽  
Medical Device Regulation

Within the healthcare environment, mobile health (mHealth) applications (apps) are becoming more and more important. The number of new mHealth apps has risen steadily in the last years. Especially the COVID-19 pandemic has led to an enormous amount of app releases. In most countries, mHealth applications have to be compliant with several regulatory aspects to be declared a “medical app”. However, the latest applicable medical device regulation (MDR) does not provide more details on the requirements for mHealth applications. When developing a medical app, it is essential that all contributors in an interdisciplinary team—especially software engineers—are aware of the specific regulatory requirements beforehand. The development process, however, should not be stalled due to integration of the MDR. Therefore, a developing framework that includes these aspects is required to facilitate a reliable and quick development process. The paper at hand introduces the creation of such a framework on the basis of the Corona Health and Corona Check apps. The relevant regulatory guidelines are listed and summarized as a guidance for medical app developments during the pandemic and beyond. In particular, the important stages and challenges faced that emerged during the entire development process are highlighted.

Review of U.S. Medical Device Regulation

2007 ◽  
Vol 1 (4) ◽  
pp. 283-292 ◽  
Author(s):  
Jan B. Pietzsch ◽  
Lauren M. Aquino ◽  
Paul G. Yock ◽  
M. Elisabeth Paté-Cornell ◽  
John H. Linehan
Keyword(s):  
Medical Device ◽  
The United States ◽  
Careful Consideration ◽  
Practical Implementation ◽  
Design Development ◽  
Regulatory Requirements ◽  
Regulatory Pathways ◽  
Device Development ◽  
Federal Food ◽  
Medical Device Regulation

Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.

Europäischer Medizinproduktemarkt: Wie sich Einkauf und Logistik auf die europäische MDR vorbereiten müssen

2019 ◽  
Vol 01 (04) ◽  
pp. 74-77
Author(s):  
Thomas Gallmann
Keyword(s):  
Medical Device ◽  
Medical Device Regulation

Nicht lieferbare Medizinprodukte sind für Kliniken ein Albtraum – mitunter müssen sogar geplante OPs abgesagt werden. Die Folge: Die mit den Kostenträgern vereinbarten Leistungszahlen sind schwieriger zu erfüllen und es könnte zu schwer kompensierbaren Erlöseinbußen für die Leistungserbringer kommen. Die Medical Device Regulation (MDR) wird die Liefersituation von Medizinprodukten ab 2020 wahrscheinlich noch weiter verschärfen.

A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

2020 ◽  
Vol 7 (3) ◽  
pp. 162-176
Author(s):  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
Vikas Rathee
Keyword(s):  
Regulatory Requirements ◽  
Health Value ◽  
Drug Products ◽  
Registration Process ◽  
Potential Market ◽  
Regulatory Guidelines ◽  
Cis Countries ◽  
In Cis ◽  
Regulatory Organization ◽  
Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

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.

scholarly journals Collaborative Modeling of Group Learning Applications Using Eclipse Technology

Proceedings ◽  
2019 ◽  
Vol 31 (1) ◽  
pp. 21
Author(s):  
Yoel Arroyo ◽  
Ana I. Molina ◽  
Miguel A. Redondo ◽  
Jesús Gallardo ◽  
Carmen Lacave
Keyword(s):  
Development Process ◽  
Group Learning ◽  
Complex Task ◽  
Learning Collaborative ◽  
Interactive Applications ◽  
Model Driven ◽  
Collaborative Modeling ◽  
Innovative Model ◽  
Software Engineers ◽  
Computer Aided Software Engineering

The design and creation of groupware tools is a complex task that usually requires the participation of different stakeholders (software engineers, designers, etc.), either working at the same time or collaborating asynchronously. This paper describes an innovative model-driven development process to support the collaborative modeling of group learning applications, as well as the Computer Aided Software Engineering (CASE) tool that technologically supports it, the Learning Collaborative Interactive Applications Tool (Learn-CIAT) graphical editor. In its development, we applied technologies integrated within the Eclipse platform. The processes and tools described in this paper supply an important contribution to systematize the design and development of these kinds of applications.

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.

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