scholarly journals When Is Software a Medical Device? Understanding and Determining the “Intention” and Requirements for Software as a Medical Device in European Union Law

2021 ◽  
pp. 1-16
Author(s):  
Kaspar LUDVIGSEN ◽  
Shishir NAGARAJA ◽  
Angela DALY
Keyword(s):  
European Union ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Equipment ◽  
First Century ◽  
Diagnosis And Treatment ◽  
European Union Law ◽  
Medical Device Regulation

The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Consequently, software plays a role comparable to medical equipment with a physical footprint. Understanding when software as a medical device must comply with applicable rules is vital for both manufacturers and regulators. We therefore examine the Medical Device Regulation to expand on the notion of intention, as this is the key basis for the classification of medical devices. Finally, we develop objective criteria that software must fulfil to be considered a medical device under European Union law.

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.

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.

Role of laparoscopic in diagnosis and treatment of undescended testis in children at Viet Duc Hospital

2018 ◽  
Vol 8 (4) ◽  
Author(s):  
Viet Hoa Nguyen
Keyword(s):  
Laparoscopic Surgery ◽  
Undescended Testis ◽  
Correct Diagnosis ◽  
Diagnosis And Treatment ◽  
Highly Sensitive ◽  
The Mean ◽  
The Right ◽  
Time Of Operation

Abstract Introduction: Evaluating the role of laparoscopic for diagnosis and treatment of undescended testis in children. Material and Methods: Restrospective study, between 6/ 2014 and 6/2017. All the patients are aged from 1 to 16 years with undescended testis underwent laparoscopic surgery for diagnosis and treatment in Deparment of pediatric surgery – Viet Duc hospital enrolled. Results: Of 95 patiens in total had 106 undescended testis diagnosed and treated by laparoscopy. The mean age of patients was 7,5 ± 3,8 years. 44,2% undescended were on the left side, 44,2% were on the right and 11,6% were undescended bilateral. The correct diagnosis by ultrasound accounted in 79,4%. The locations of testis diagnosed by laparoscopic are : intra abdomen in 45,3%, deep inguinal orifice in 16,9%, extra inguinal orifice in 26,4%, no testicle found in 11,4%. The mean time of operation were 67,33± 28,01 pht. Scrotal positions were achieved 74,5%, remove atrophic testis accounted in 7,6%. Stephen- Flowler technique including step I were in 4,7%, step II in 1,9%. The outcome evaluated by testicular positions following 3 months after operation are : good in 79,2%, moderate 13,2%, poor in 7,6%; By classification of Aubert are : good in 81,1%, moderate in 11,3% and poor in 7,6 %. Conclusion: Laparoscopic surgery is not only a highly sensitive diagnostic method to find accurately the location and size of the testes, but also the most effective method to treat impalpable undescended testes.

IMPACT OF THE ROLE OF THE JURISPRUDENCE OF THE EUROPEAN UNION COURT OF JUSTICE IN THE FIELD OF ENVIRONMENTAL PROTECTION

2018 ◽  
Vol 4 (2) ◽  
pp. 77-89
Author(s):  
Anna Kęskiewicz
Keyword(s):  
European Union ◽  
Environmental Protection ◽  
Environmental Law ◽  
Point Of View ◽  
The European Union ◽  
European Union Law ◽  
Court Of Justice ◽  
The Law ◽  
Law Making

The use of dogmatic-legal, empirical and linguistic semantics methodology is focused on sharing for better understanding of the law. Therefore, views on European jurisprudence have been presented in the paper. Without a doubt, the law-making nature of European Union law takes into account the field of environmental protection. Articles in law define the tasks that are important from the point of view of European legislation. The written nature of these determinants of the reasoning of the possibilities of environmental protection plays an important role in the interpretation of environmental law.

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