For the exporter, therefore, Europe as a whole has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all that.

Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer's product or as a means of recognition of the manufacturer's credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment.

The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive. “CE” refers to Communauté Européen. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a “passport” for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.

The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity.

2014/35/EU

An Authorized Representative is the person appointed by the manufacturer and delegated to act on his or her behalf in carrying out certain tasks required by a New Approach Directive. This Authorized Representative must be established inside the European Union and available to Member State Authorities. The manufacturer, however, is ultimately responsible for the actions carried out by the Authorized Representative.

Manufacturers established outside the European Union are not necessarily required to have an Authorized Representative in the European Union. There are exceptions, however. Manufacturers who do not have a registered place of business in a Member State and whose products are governed by the Directives for Medical Devices, Active Implantable Devices and In-vitro Diagnostic Devices, must appoint an Authorized Representative established within the European Union.

• Registering of your product with the Authorities before they are marketed (if necessary);

• Keeping your technical file documentation ready and available for the European Competent Authorities;

• Be responsible for incident reporting before Competent Authorities, in close liaison with the Manufacturer and distributors;

• Product Notification of serious incidents to the Competent Authorities;

• Represent the Manufacturer to the European Commission for consultation in case of withdrawal of a Product by a Member State (s);

• Keep at the disposal of the Competent Authorities report concerning the evaluation of all data collected during the evaluation;

• Represent the Manufacturer before the national Competent Authorities in the European Economic Area;

• Be available at all times to interact between the Manufacturer and the national Competent Authorities;

• Be informed by the Competent Authorities of any incident (s);

• Notify the Competent Authorities as to which investigations are to be conducted;

• Act as your primary contact point for the EU Authorities;

• Protect your confidentiality documentation because the Authorized Representative is authorized to show them to the Competent Authorities only.