Medical Device Regulation: Implications for dental nurses

2021 ◽  
Vol 17 (1) ◽  
pp. 44-45
Author(s):  
James I J Green
Keyword(s):  
Medical Device ◽  
James I ◽  
Custom Made ◽  
Legislative Changes ◽  
Medical Device Regulation

James I J Green explores the legislative changes that will be affecting custom-made devices and what this means for dental nurses

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 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.

scholarly journals Development and manufacturing of a custom made implant regarding the new European Medical Device Regulation

2019 ◽  
Vol 5 (1) ◽  
pp. 253-256
Author(s):  
Mareike Schonhoff ◽  
Astrid Heinze ◽  
Juliette Carrillo ◽  
Annika Lopinski ◽  
Damian Großkreutz ◽  
...  
Keyword(s):  
Medical Device ◽  
Electron Beam Melting ◽  
New Technologies ◽  
Pelvic Bone ◽  
The European Union ◽  
Bone Contact ◽  
Reconstruction Process ◽  
Custom Made ◽  
Modular Implant ◽  
Medical Device Regulation

AbstractNew technologies are great opportunities for personalized medicine. Custom made implants can be very helpful for patients with severe bone defects or in case of bone tumor. Through the European Union it is regulated how many possibilities and restrictions all medical devices have. Because of critical vulnerabilities a new European Medical Device Regulation (MDR) was published in May 2017 and it will enter into force in May 2020. For the manufacturers of customized products it will change the documentation of the manufacturing and tracking of serious incidents. Patients with a pelvis defect of Paprosky IIb and higher can benefit from a custom made pelvis implant, because all planning steps according to biomechanic and bone contact to the implant can be designed and proofed during a reconstruction process. With regular modular implant systems, it probably can be a trial and error procedure during the surgery according to biomechanic and a stable position of the implant. Based on the 3D-Reconstruction of CT-Scans of a patient with a Paprosky 2b pelvis defect, a personalized acetabulum implant was designed. To maintain as much bone as possible, the implant was shaped to the remaining pelvic bone stock. Additive manufacturing gives the opportunity to produce custom made single items even in a quality that ful-fills the requirements of the MDR. Modern Selective Laser Melting (SLM) and Electron Beam melting (EBM) Systems are able to produce Titanium or CoCr parts in the ISO standards for Implants (ISO 5832 ff). In this study the process chain, starting from the reconstruction, to the design and the production of a custom made acetabulum cup was run through on an exemplary CTData of one patient. With this example, it was shown that it is possible, to establish a process, that is able to address surgical needs for patients that benefit from those techniques.

The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices

2020 ◽  
Vol 81 (12) ◽  
pp. 1-6
Author(s):  
James IJ Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
European Directives ◽  
Custom Made ◽  
Hospital Doctors ◽  
Safety Effectiveness ◽  
The Impact ◽  
Medical Device Regulation

The 1990s saw the implementation of three European directives that aimed to standardise medical device legislation. EU regulations replace and repeal these directives, to improve the safety, effectiveness and traceability of medical devices. This article discusses the implications of the Regulation (EU) 2017/745 (Medical Device Regulation) for hospital doctors who prescribe and manufacture custom-made medical devices.

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.

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’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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