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.

scholarly journals Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations

2021 ◽  
Vol 34 (3) ◽  
pp. 201
Author(s):  
Carla Pires ◽  
Dinah Duarte ◽  
Afonso Cavaco
Keyword(s):  
European Union ◽  
Medical Device ◽  
Medical Devices ◽  
Text Message ◽  
Open Market ◽  
The European Union ◽  
Counterfeit Products ◽  
National Competent Authorities ◽  
European Union Member States ◽  
Regulatory Actions

Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations.Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany.Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices.Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts.Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.

ANTI-SUIT INJUNCTIONS IN ARBITRAL AWARDS: ENFORCEMENT IN EUROPE

2015 ◽  
Vol 74 (3) ◽  
pp. 412-415
Author(s):  
Ewelina Kajkowska
Keyword(s):  
European Union ◽  
Member State ◽  
State Courts ◽  
The European Union ◽  
Court Of Justice ◽  
The Status ◽  
Recognition And Enforcement ◽  
The Relationship ◽  
Brussels Regulation

THE status of anti-suit injunctions in Europe has long given rise to controversy. The decision of the Court of Justice of the European Union in Case C-536/13, Gazprom OAO [2015] All E.R. (EC) 711 sheds a new light on the relationship between anti-suit injunctions and the European jurisdiction regime embodied in the Brussels Regulation (Regulation No. 44/2001 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters). In this much anticipated judgment, the Court of Justice confirmed that, by virtue of the arbitration exclusion in Article 1(2)(d) of the Brussels Regulation, Member State courts are not precluded from enforcing anti-suit injunctions issued by arbitration tribunals and aimed at restraining the proceedings before Member State courts. Although the decision was given before the Recast Brussels Regulation came into force (Regulation No. 1215/2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, effective from 10 January 2015), it can be assumed that the same conclusion would have been reached under the new law.

scholarly journals Los procesos secesionistas y el derecho europeo

2016 ◽  
pp. 347
Author(s):  
Javier Tajadura Tejada
Keyword(s):  
European Union ◽  
Member State ◽  
Legal System ◽  
Constitutional Law ◽  
The Political ◽  
European Law ◽  
The European Union ◽  
European Citizenship ◽  
Regional Authorities

Este artículo analiza en primer lugar el significado de la secesión en el Derecho Internacional y en el Derecho Constitucional. Asimismo, examina cómo se aborda el fenómeno de la secesión en el Derecho comunitario europeo. Esto obliga a estudiar dos tipos de problemas: por un lado, el de la secesión de un Estado miembro respecto de la propia Unión; por otro, el de la fragmentación de un Estado miembro por la secesión de una parte de su territorio. La conclusión es que la conservación o fragmentación de un Estado miembro de la Unión Europea no es un asunto interno: la secesión de partes de un territorio afecta al sistema político europeo en su conjunto, en la medida en que es una forma de integración federal donde no caben actos unilaterales que quebranten el principio de lealtad federal de la Unión y la ciudadanía europea que ha ido conformándose en las últimas décadas.This article analyzes the meaning of secession in international and constitutional law. It also examines the phenomenon of secession in European law. This requires studying two types of problems: the secession of a member state of the European Union and the fragmentation of a Member State for the secession of part of its territory. The conclusion is that conservation or fragmentation of a Member State of the European Union is not an internal matter. In our opinión, the political and legal system of the Union can be characterized also federally, which prevents the national and regional authorities to carry out unilateral acts that go against the principle of Community federal loyalty and European citizenship.

scholarly journals Protection of fundamental rights in the private law of the European Union

2020 ◽  
Vol 2 (2) ◽  
pp. 117-153
Author(s):  
Tatjana Josipović
Keyword(s):  
European Union ◽  
Member State ◽  
Fundamental Rights ◽  
Private Law ◽  
Eu Law ◽  
The European Union ◽  
Freedom Of Contract ◽  
Optimal Balance ◽  
Private Autonomy

The paper considers and comments on the instruments of protection of the fundamental rights of the Union in private law relationships that are in the scope of applicable EU law. Special attention is paid to the influence of fundamental rights of the Union on private autonomy and the freedom of contract in private law relationships depending on whether fundamental rights are protected by national law harmonized with EU law, or by horizontal effects of the Charter of general principles. The goal of the paper is to determine the method in private law relationships that can attain the optimal balance between the protection of fundamental rights of the Union and the principle of private autonomy and the freedom of contract regulated by national law of a member state. The author favors the protection of fundamental rights in private law relationships by applying adequate measures that create indirect horizontal effects of the provisions of EU law on fundamental rights. These concern national measures that can also secure adequate protection of fundamental rights via interpretation and application of national law in line with EU law in private law relationships.

scholarly journals Polish “Entrepreneur” and EU “Undertaking”: Multilingualism and Differences in Legal Identification

2017 ◽  
Vol 52 (1) ◽  
pp. 57-71
Author(s):  
Maciej Etel
Keyword(s):  
European Union ◽  
Member State ◽  
Precise Determination ◽  
Eu Law ◽  
The European Union ◽  
Economic Sphere ◽  
Polish Law ◽  
Legal Identification ◽  
The Eu

Abstract The European Union and its member-states’ involvement in the economic sphere, manifesting itself in establishing the rules of entrepreneurs’ functioning – their responsibilities and entitlements – requires a precise determination of the addressees of these standards. Proper identification of an entrepreneur is a condition of proper legislation, interpretation, application, control and execution of the law. In this context it is surprising that understanding the term entrepreneur in Polish law and in EU law is not the same, and divergences and differences in identification are fundamental. This fact formed the objective of this article. It is aimed at pointing at key differences in the identification of an entrepreneur between Polish and EU law, explaining the reasons for different concepts, and also the answer to the question: May Poland, as an EU member-state, identify the entrepreneur in a different way than the EU?

scholarly journals Relationship between national, international and European law within the constitutional review in Romania

2016 ◽  
pp. 91-107
Author(s):  
TUDOREL TOADER ◽  
MARIETA SAFTA
Keyword(s):  
European Union ◽  
Member State ◽  
Legal Order ◽  
Constitutional Court ◽  
European Law ◽  
The European Union ◽  
International Treaties ◽  
Constitutional Review ◽  
Exclusive Jurisdiction ◽  
Constitutional Identity

The Constitutional Court has ruled that, by adhering to the legal order of the European Union, Romania agreed that, in those areas where exclusive jurisdiction is conferred on the European Union, regardless of the international treaties priorly signed, implementation of its obligations arising therefrom is subject to the rules of the European Union. Otherwise, this would result in the undesirable situation where, through bi or multilateral internationally assumed obligations, Member State would seriously affect the Union’s competence and, in practice, would act in its place in the aforementioned areas. For this reason, in the field of competition, any State aid falls within the competence of the European Commission and appeal proceedings fall within the jurisdiction of the European Union. Therefore, pursuant to Article 11 para. (1) and Article 148 para. (2) and (4) of the Constitution, Romania applies in good faith the obligations resulting from the Accession Instrument, without interfering with the exclusive competence of the European Union and, by virtue of the compliance clause contained in the text of Article 148 of the Constitution, Romania cannot adopt a legislative act contrary to the obligations assumed as a Member State. All those already highlighted are subject to certain limitations, expressed in what the Court described as “national constitutional identity”.

Always One Step Behind? National Legislatures and the European Union

1999 ◽  
Vol 34 (2) ◽  
pp. 180-202 ◽  
Author(s):  
Tapio Raunio
Keyword(s):  
European Union ◽  
Member State ◽  
National Policy ◽  
Policy Formulation ◽  
The European Union ◽  
National Parliaments ◽  
State Constitutions ◽  
Eu Membership ◽  
One Step ◽  
Council Of Ministers

NATIONAL PARLIAMENTS ARE CENTRAL ACTORS IN THE SCRUTINY AND implementation of European Union (EU) legislation. Member state legislatures provide a channel for incorporating public opinion into the governance of the Union. Their importance has become more evident during the 1990s as debate has focused on the democratic deficit and deparliamentarization of European governance.National parliaments are involved in EU decision-making in three ways: they 1) participate in national policy formulation on Union legislation; 2) monitor the behaviour of member state representatives in the Council of Ministers and the European Council; and 3) have functions specifically regulated in the treaties, such as ratification of treaty amendments and implementation of directives. The third function differs from the first two as the treaties impose rights and duties on the national parliaments, whereas there is no EU law on national policy formulation on Union legislation or on the scrutiny of ministers. During the 1996-97 Intergovernmental Conference (ICC) the member states saw no need for such European-level regulation. Thus it is up to each national parliament – within the limits set by member state constitutions and other constraints – to decide how it deals with the challenges brought by EU membership.

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