scholarly journals Regulating drugs, medical devices, and diagnostic tests in the European Union: early lessons from the COVID-19 pandemic?

2020 ◽  
Vol 41 (23) ◽  
pp. 2140-2144 ◽  
Author(s):  
Alan G Fraser ◽  
Piotr Szymański ◽  
Elizabeth Macintyre ◽  
Martin Landray
Keyword(s):  
European Union ◽  
Medical Devices ◽  
Diagnostic Tests ◽  
The European Union

A Regulatory and Safety Perspective on Medical Devices

2021 ◽  
pp. 1815-1826
Author(s):  
Carla Pires ◽  
Dinah Duarte
Keyword(s):  
European Union ◽  
Adverse Events ◽  
Member State ◽  
Medical Devices ◽  
Future Development ◽  
The European Union ◽  
Serious Adverse Events ◽  
International Laws ◽  
Counterfeit Products

In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safety alerts on MD of a member state of EU in 2017. International laws were used to define MD. Examples and safety alerts of MD of the Portuguese medicine agency were considered. MD are not medicines, but they have a medicinal application. MD are classified in Classes I-III. Only 32 safety alerts were identified in Portugal, none related to serious adverse events, and 6 related to devices voluntarily withdrawal from the market, for example, counterfeit products. The concept of MD is clearly defined in regulations. Although alerts on MD are limited, falsified products were identified in EU market, which is extremely regulated. For instance, future development of safety, traceable, and economic devices is very important to assure, patients' safety and access.

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 European Union

2020 ◽  
Author(s):  
Aurélie Mahalatchimy
Keyword(s):  
European Union ◽  
Medical Devices ◽  
The United States ◽  
The European Union ◽  
Public And Private ◽  
European Regulatory ◽  
Notified Body ◽  
Private Actors ◽  
Intended Use ◽  
The Eu

This chapter addresses the regulation of medical devices in the European Union. The overall goals of the European regulatory framework for medical devices are the same as the goals of the framework for medicines. It aims to protect public health by ensuring that medical devices are of good quality and safe for their intended use. However, the regulation of medical devices in Europe is very different from the regulation of medicines in two regards. First, unlike medicines, there is no pre-market authorisation by a regulatory authority for medical devices to lawfully enter the EU market. Second, unlike in the United States where the Food and Drug Administration is the primary regulator of devices throughout the nation, the European Union does not have a single regulator of medical devices. Instead, several organisations may be involved, and mainly a notified body in specific cases. The chapter then explains what constitutes a medical device in the EU and how devices are classified according to their level of risk in the EU. It then discusses how medical devices reach the market, how their risks are managed all along their lifecycle, and what kinds of incentives are provided for innovation and competition. The chapter also analyses the balance between public and private actors in the regulation of medical devices. It then concludes with case studies of innovative medical technologies that have challenged the traditional European regulatory scheme and that have led to many revisions in the 2017 device regulations.

Regulatory Assessment of Premarket Approval of Medical Devices in US and EU

2017 ◽  
Vol 9 (04) ◽  
Author(s):  
M.P. Venkatesh ◽  
Divya Bandla
Keyword(s):  
United States ◽  
European Union ◽  
Medical Devices ◽  
The United States ◽  
The European Union ◽  
Class Iii ◽  
Risk Class ◽  
Class Iib ◽  
Set Up ◽  
Premarket Approval

The demand for medical devices globally has raised the attention of government regulatory bodies to ensure the safety and effectiveness of these products. Developed markets, such as the United States and European Union, have set up wellestablished regulatory systems for medical devices, which have consistently been amended to accommodate the changing requirements of safety and the trend of globalization. The way in which devices are regulated in the European Union is very different from that of United States, especially in terms of the clinical data required for premarket approval. This has introduced significant differences in time-to-market approval for both United States and European Union, particularly in the case of high-risk Class III and Class IIb implantable devices. Systems for approving new medical devices must provide pathways to market important innovations besides ensuring that patients are adequately protected. To achieve these goals, the United States and the European Union use a combination of premarket testing and postmarket vigilance but with some marked contrasts in their approaches. Features of both environments require reform, as well as continuing research to assess policy changes which will benefit device manufacturers to develop devices which can be marketed both in US and EU simultaneously

scholarly journals How are medical devices regulated in the European Union?

2012 ◽  
Vol 105 (1_suppl) ◽  
pp. 22-28 ◽  
Author(s):  
Elaine French-Mowat ◽  
Joanne Burnett
Keyword(s):  
European Union ◽  
Medical Devices ◽  
The European Union

US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States

2013 ◽  
Vol 4 (4) ◽  
pp. 443-464
Author(s):  
Christa Altenstetter
Keyword(s):  
United States ◽  
European Union ◽  
Medical Devices ◽  
The United States ◽  
Interdisciplinary Studies ◽  
Lessons Learned ◽  
Science Literature ◽  
The European Union ◽  
The U.S ◽  
The Eu

The literature on the regulation of drugs at the FDA and the European Union is substantial, yet little research has provided comparative analyses and robust empirical data on the regulation of medical devices in the United States and the European Union. As medical and health markets become increasingly globalized, and the U.S. and the EU compete for leadership and recognition, salient domestic regulatory issues are becoming increasingly international and transnational policy issues. Building on Carpenter's (2010) work on drug regulation at the FDA, but taking a slightly narrower yet at the same time a broader approach by drawing on interdisciplinary studies instead of limiting ourselves to only the Political Science literature, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.

scholarly journals Artificial Hair: By the Dawn to Automatic Biofibre® Hair Implant

2017 ◽  
Vol 6 (1) ◽  
pp. 156-162 ◽  
Author(s):  
Maria Roccia ◽  
Katlein França ◽  
David Castillo ◽  
Georgi Tchernev ◽  
Uwe Wollina ◽  
...  
Keyword(s):  
Twentieth Century ◽  
European Union ◽  
North America ◽  
Medical Treatment ◽  
Medical Devices ◽  
Medical Personnel ◽  
The European Union ◽  
Restoration Technique ◽  
Appropriate Treatment ◽  
Improper Use

Since the beginning of the twentieth century, there have been attempts at creating artificial hair to treat baldness. Major evolution took place at the end of 1970’s when, unfortunately, artificial hair treatments were applied without appropriate medical controls, resulting in sub-standard results from the use of unsuitable materials and technique. The large improper use of this technique in North America from no medical personnel and with dangerous fibres led the Food and Drug Administration (FDA) to suspend the procedure in 1983. In Europe, a new trial on artificial hair procedure started at the beginning of 1990’s.In 1995 the European Union (UE) recognised the artificial hair implant as a legitimate medical treatment and outlined the rules related to that procedure. In 1996, biocompatible fibres (Biofibre®) produced by Medicap® Italy were approved by the UE Authorities and by the Australian Therapeutic Goods Administration (TGA) as medical devices for hair implant. An effective medical protocol was developed during the following years to provide correct guidelines for appropriate treatment, and to reduce possible related complications. Automatic Biofibre® hair implant represents the last achievement in this hair restoration technique with significant advantages for the patients.

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