scholarly journals Technical Documentation Requirements for Medical Devices Approval in European Union and a Detailed Emphasis on Air-way Products

2021 ◽  
pp. 48-53
Author(s):  
Shanmukhi Kondrath ◽  
Ramaiah Maddi
Keyword(s):  
European Union ◽  
Medical Devices ◽  
Technical Documentation ◽  
Theoretical Level ◽  
Administrative Control ◽  
Current Article ◽  
The Way

The technical documentation to be drawn up by the maker ought to be introduced in an unmistakable, coordinated, promptly accessible, and unambiguous way. It will remember for specific the components recorded as per Annex II of EU MDR 2017/745. The Air-Way is the way that air follows to get into and out of the lungs. There are a few kinds of Air-way devices are there on the lookout. New items will conceivably further develop patient prosperity altogether however will require sensible administrative control to boost the advantages. The orderly methodology is planned on a central theoretical level that underlies the substantial necessities that could be changed during the years to follow. The current article gives an itemized accentuation on Air-way items and their tech documentation necessities.

Dochodzenie roszczeń ze sprzedaży towarów w obrocie międzynarodowym na obszarze UE. Zagadnienie jurysdykcji

2016 ◽  
pp. 107-122
Author(s):  
Agata Michalska-Olek
Keyword(s):  
European Union ◽  
European Parliament ◽  
The European Union ◽  
Community Law ◽  
Judicial Decisions ◽  
Cross Border ◽  
National Jurisdiction ◽  
Recognition And Enforcement ◽  
The Way

The article aims to show the possible ways of judicial redress for claims resulting from sales of goods especially including the issue of jurisdiction and application of the provisions of national law or the provisions of Community law. In the article the provisions of the Convention of 30 October 2007 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters as well as the provisions of regulations of the European Parliament and of the Council were widely discussed. The author discusses in particular the issue related to cross-border contracts for the sales-of-goods within the European Union. Part of the deliberations concerns judicial rulings, in particular judicial decisions issued in cases in which the court shall consider the issue of jurisdiction of its own motion. In the conclusion of the article it is stated that the choice between the national jurisdiction and the jurisdiction of other states will depend on the terms of agreement between the parties as well as the documents related to the transaction, in particular consignment notes (CMR), and the EXW clauses – such a formulation means that the parties agreed to the way of delivery of goods according to the commercial (Incoterms) clauses, determining in such a way the issue of jurisdiction.

De structuur van de besluitvorming in de Raad van de Europese Unie

Res Publica ◽  
1994 ◽  
Vol 36 (3-4) ◽  
pp. 381-398
Author(s):  
Jan Beyers
Keyword(s):  
Decision Making ◽  
European Union ◽  
Functional Approach ◽  
Council Decision ◽  
Working Groups ◽  
Definition Of ◽  
The Impact ◽  
The Way

In spite of its importance in European Union decision making, research on the functioning of the Council is scarce (Wessels, 1991). Based on empirical findings this article gives some new insights in the way Council decision making is institutionalized. The first part focusses on the characteristics of Council working groups and the different positions of actors in the decision making network. Our findings confirm the definition of the Council as a highly bureaucratized institution. Interesting is that the diversity of tasks of the different actors(working groups, Coreper, CSA etc.) strengthens the impact of national administrations in Council decision making. The second part explores the reasons for this impact. This article adds to the functional approach, which over-emphasizes the adaptive character of the Council, the perception of the Council as an intergovernmental component in a supranational system.

The Google Ireland Case and the Legal Battle over Digital Taxes in the European Union

2021 ◽  
Vol 14 (1) ◽  
pp. 209-220
Author(s):  
Giulio Allevato ◽  
Fernando Pastor-Merchante
Keyword(s):  
European Union ◽  
Digital Economy ◽  
Free Movement ◽  
Preliminary Ruling ◽  
The European Union ◽  
Topical Issue ◽  
Member States ◽  
Court Of Justice ◽  
Legal Battle ◽  
The Way

The preliminary ruling of the Court of Justice of the European Union in the Google Ireland case turned on the compatibility with the rules on free movement of some of the administrative arrangements put in place by Hungary in order to administer its controversial advertisement tax (namely, the obligation to register and the penalties attached to the failure to comply with that obligation). The preliminary ruling offers some interesting insights on the way in which the Court assesses the compatibility with the freedom to provide services of national administrative arrangements aimed at ensuring the effective collection of taxes. This is a topical issue in the context of the recent efforts made by Member States to tax the digital economy more effectively.

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.

2 Parties and Group Litigation

2019 ◽  
Author(s):  
Brealey Mark ◽  
George Kyla
Keyword(s):  
European Union ◽  
The European Union ◽  
High Court ◽  
Different Types ◽  
Parent Companies ◽  
The Way

This chapter discusses the special considerations that apply to identifying the relevant parties in competition litigation as well as the way that claimants may group together to commence collective proceedings. It first explains private actions in the High Court, with emphasis on the nature of claimant and defendant. It considers the category of claimant under Articles 101 and 102 of the Treaty on the Functioning of the European Union (TFEU) and under the Competition Act 1998, along with the concept of ‘undertaking’, parent companies, subsidiary companies, and sister companies in relation to the defendants. The chapter also examines representative actions in the High Court during group litigation, collective proceedings in the Competition Appeal Tribunal (CAT), and settlement of collective proceedings. Different types of collective settlement are highlighted.

Remedies Before National Courts

2018 ◽  
Author(s):  
Anthony Arnull
Keyword(s):  
European Union ◽  
European Union Law ◽  
National Courts ◽  
Court Of Justice ◽  
The Way

This chapter is concerned with the decentralized enforcement of European Union law, that is, the way in which national courts uphold the rights it confers on litigants. When the Court of Justice established in Van Gend en Loos that Union law was capable of conferring on litigants rights which the national courts were bound to protect, it had written only the first sentence (albeit a very striking one) of a long and complex story that remains unfinished. For while the Court in Van Gend en Loos had enlisted the help of the national courts in ensuring that Union law was observed, it had not made clear how exactly it expected them to discharge that responsibility. The Union legislature might have attempted to resolve the issue systematically and today there is a significant body of Union legislation dealing with the remedies national courts must provide in discrete areas. However, such legislation was slow to develop and remains piecemeal in nature. This has meant that much of the responsibility for fleshing out the remedial obligations of national courts when seeking to uphold rights granted by Union law has fallen to the Court of Justice.

Six Dimensions of Public Law

2020 ◽  
pp. 399-430
Author(s):  
Paul Craig
Keyword(s):  
European Union ◽  
United Kingdom ◽  
Case Law ◽  
Public Law ◽  
The European Union ◽  
The Public ◽  
The United Kingdom ◽  
Six Dimensions ◽  
The Impact ◽  
The Way

This chapter draws on the six dimensions of public law covered in the book: theory, institutions and accountability, constitutions and rights, process and procedure, legislation, and case law. It links discussion of these dimensions, by considering how they have been affected by Brexit. The chapter is not concerned with the contending arguments for leaving or remaining in the European Union. The focus is on the way in which Brexit has ‘pressure-tested’ the public law regime in the United Kingdom and the European Union. The six dimensions of public law that are discussed in the preceding chapters form the architectural frame through which the impact of Brexit on the public law regimes is assessed in both the United Kingdom and the European Union.

A moveable feast—economic substance and holding entities

2019 ◽  
Vol 25 (10) ◽  
pp. 969-977
Author(s):  
Ashley Fife
Keyword(s):  
European Union ◽  
International Business ◽  
Due Diligence ◽  
The European Union ◽  
Exchange Of Information ◽  
The Impact ◽  
The Way

Abstract The economic substance requirements that the European Union insisted that a number of international financial centres introduce may be the most complex and far-reaching of international initiatives to impact on those jurisdictions in recent years. The requirements extend beyond due diligence, reporting and exchange of information to potentially impact on the way in which entities resource and carry on business in or from those jurisdictions. However, not all sectors of international business are impacted in the same way or to the same extent. This article considers certain aspects of the economic substance requirements relevant to private client structures, with a particular focus on the impact on holding entities. The treatment of holding entities under economic substance legislation in a number of C.2.2 jurisdictions may not be settled and this article explores how it may evolve.

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