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NIST SP 951
Mutual Recognition AgreementsIn December 1998, The European Union and the United States concluded Mutual Recognition Agreements (MRAs) on conformity assessment. The U.S. - EU MRA is a bilateral agreement between the United States and the European Union that establishes procedures to facilitate transatlantic trade. The MRA recognizes that certain conformity assessment bodies (CABs) in Europe can conduct - in accordance with U.S. regulatory requirements - product approval type testing and quality system evaluations in a fashion equivalent to those conducted by the FDA. Similarly, it recognizes that CABs in the United States can conduct type testing and quality evaluations according to the EU Medical Device Directive. The agreements cover several industrial sectors and are based on acceptance by both Parties of test reports, certificates, and reports of inspections issued by one another's conformity assessment bodies (CABs) and authorities. MRAs include lists of conformity assessment bodies, inspection bodies, and authorities, in both the EU and the United States. The full text of the U.S.- EU MRA can be accessed at http://www.mac.doc.gov/mra/mra.htm EC Type-ExaminationThe EC type-examination is a procedure by which the Notified Body ascertains and attests that a specimen representative of production meets the provisions of the directive that applies to it. The manufacturer or his Authorized Representative established in the European Union may make application to the Notified Body of his choice. ManufacturerThe manufacturer is the person responsible for designing and manufacturing a product covered by a New Approach Directive, and whose intention is to place it on the European Union market. A manufacturer may contract out the design or production, may use finished products, parts or components. In all cases, however, he or she is ultimately responsible for the product and its compliance with the law. The manufacturer is responsible for designing and manufacturing the product in accordance with the essential requirements of all relevant directives and following the conformity assessment procedures from the appropriate directives, such as compiling a Technical File, affixing the CE marking and drawing up of a Declaration of Conformity. A manufacturer may be located inside or outside the European Union. Inside or out, he or she can appoint an Authorized Representative (who must be located in the European Union) to act on his or her behalf. A person producing a new end product by assembling other existing products is also considered a manufacturer, and acquires the responsibilities of a manufacturer. The same is true of a person who changes the usage of a product, such as adding a new function to a machine or changing an existing function. The law treats these "modified" products as new products, and they are held to the same certification requirements as any other new product. Return to the Table of Contents
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