A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article Devices that are manufactured and used within health institutions shall be considered as having been put into service. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met:
The same treaty specifies that the European Union shall not interfere with the competences of its members states, which are sovereign in defining all means to assure that constructions satisfy their set objectives for health, security and protection.
Mechanical resistance and stability Safety in case of fire Hygiene, health and the environment Safety and accessibility in use Protection against noise Energy economy and heat retention Sustainable use of natural resources Further the CPR states that Construction works as a whole and in their separate parts must be fit for their intended use The CE marking expresses the conformity of the characteristics of the building product to these essential characteristics and the fulfillment of the applicable requirements of the harmonized EU legislation.
Thus, with the CE marking of construction products, the manufacturer takes on both responsibilities, the conformity of the product and the fulfillment of the essential characteristics.
The CE marking shall be applied to the product itself and where this should be not be possible to the packaging or accompanying documents. This first phase is followed by a factory audit, with which the appointed notified body verifies if the quality system of the manufacturer at his factory can assure over time constancy in order to preserve for the serial production the declared essential characteristics of the tested specimen.
A positive audit leads to the issuing by the notified body of the Certificate of Constancy of Performance with which the manufacturer is authorized to issue the Declaration of Performance for his certified construction product.
Responsibilities of economic operators[ edit ] This EU regulation distinguishes two moments during the distribution of construction products: Making available on the market means any supply for distribution or use on the Union market in the course of commercial activity be it for payment or free of charge.
The first time a product is made available is therefore defined as placing on the market. Only manufacturers or importers can place products on the market, whereas distributors, importers and manufacturers can make them available thereafter.
Contrary to common practice and knowledge the manufacturer is not exclusively responsible for a compliant making available of the product.
Also, an importer or distributor may be considered to act as a manufacturer and is thus subject to all obligations for manufacturers in cases where he places a product on the market under his name or trademark or modifies a construction product already placed on the market.
Even though not expressively stated in the CPR, the DoP and all accompanying documents are considered legal documents and shall not be altered but supplied as they have been provided by the manufacturer.Ajit Pai is the Chairman of the Federal Communications Commission.
|Chapter I - SCOPE AND DEFINITIONS||The same treaty specifies that the European Union shall not interfere with the competences of its members states, which are sovereign in defining all means to assure that constructions satisfy their set objectives for health, security and protection. Mechanical resistance and stability Safety in case of fire Hygiene, health and the environment Safety and accessibility in use Protection against noise Energy economy and heat retention Sustainable use of natural resources Further the CPR states that Construction works as a whole and in their separate parts must be fit for their intended use|
|EUR-Lex - R - EN - EUR-Lex||These texts are referred to in our briefing notes on this microsite. However, this has now been delayed by one year, so that the legislation will become effective by 3 January|
|Solvency II: Remuneration requirements | Bank of England||Maritime transport Road traffic and safety In each of these areas, the mission and strategic objectives for the function are set out, the key issues are highlighted, and policies for addressing these issues are stated.|
He was designated Chairman by President Donald J. Trump in January He had previously served as Commissioner at the FCC, appointed by then-President Barack Obama and confirmed unanimously by the .
This is a big document and can take up to 30 minutes to download. Mr SinclairThe Legal Advisers have helped me in redrafting the opening passage of that draft and IThe above listed Cabinet document(s), which was/were enclosed on this file. Regulation is a key tool for achieving the social, economic and environmental policy objectives of governments.
Governments have a broad range of regulatory schemes reflecting the complex and diverse needs of their citizens, communities and economy.
[ Top] EXPLANATIONS OF TERMINOLOGY. Concession - is the authority and contract to operate a road, rail line, or network at an agreed price.
It could be awarded to either the public or private sector. Contract - is an agreement between an authority and an operator regarding the delivery of a service at an agreed price..
Framework - is an outline or skeleton which provides the structure and form. Title II Regulations Revised Final Title II Regulation with Integrated Text. NOTE: These provisions update the relevant portions of the title II regulation to incorporate changes made to the regulatory text through October 11, The following is the Department´s title III ADA regulation published July 26, , which should continue to be used until March 14,