European

European, or Europeans, may refer to:

See also

European Union

The European Union (EU) is a politico-economic union of 28 member states that are located primarily in Europe. It covers an area of 4,324,782 km², with an estimated population of over 508 million. The EU operates through a system of supranational institutions and intergovernmental-negotiated decisions by the member states. The institutions are: the European Parliament, the European Council, the Council of the European Union, the European Commission, the Court of Justice of the European Union, the European Central Bank, and the Court of Auditors. The European Parliament is elected every five years by EU citizens.

The EU has developed an internal single market through a standardised system of laws that apply in all member states. Within the Schengen Area, passport controls have been abolished. EU policies aim to ensure the free movement of people, goods, services, and capital, enact legislation in justice and home affairs, and maintain common policies on trade,agriculture,fisheries, and regional development. The monetary union was established in 1999 and came into full force in 2002. It is currently composed of 19 member states that use the euro as their legal tender.

Regulation (European Union)

A regulation is a legal act of the European Union that becomes immediately enforceable as law in all member states simultaneously. Regulations can be distinguished from directives which, at least in principle, need to be transposed into national law. Regulations can be adopted by means of a variety of legislative procedures depending on their subject matter.

Legal basis

The legal basis for the enactment of regulations is Article 288 of the Treaty on the Functioning of the European Union (formerly Article 249 TEC).

The Council can delegate legislative authority to the Commission and, depending on the area and the appropriate legislative procedure, both institutions can make laws. There are Council regulations and Commission regulations. Article 288 does not clearly distinguish between legislative acts and administrative acts, as is normally done in national legal systems.

Legal effect

Regulations are in some sense equivalent to "Acts of Parliament", in the sense that what they say is law and they do not need to be mediated into national law by means of implementing measures. As such, regulations constitute one of the most powerful forms of European Union law and a great deal of care is required in their drafting and formulation.

Medical device

A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug). Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means.

Medical devices vary greatly in complexity and application. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering.

The global medical device market reached roughly $209 billion in 2006.

Design, prototyping, and product development

European Commission

The European Commission (EC) is the executive body of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. Commissioners swear an oath at the European Court of Justice in Luxembourg, pledging to respect the treaties and to be completely independent in carrying out their duties during their mandate.

The Commission operates as a cabinet government, with 28 members of the Commission (informally known as "commissioners"). There is one member per member state, though members are bound to represent the interests of the EU as a whole rather than their home state. One of the 28 is the Commission President (currently Jean-Claude Juncker) proposed by the European Council and elected by the European Parliament. The Council then appoints the other 27 members of the Commission in agreement with the nominated President, and the 28 members as a single body are then subject to a vote of approval by the European Parliament. The current Commission is the Juncker Commission, which took office in late 2014.