products (such as invasive medical devices, or fire alarm and extinguisher systems, Pressure Equipment, Lifts etc.) in most cases, have a mandatory requirement for the involvement of an authorised third party e.g. a "notified body". There are various attestation routes which include: An assessment of the product by the manufacturer. An assessment of the product by the manufacturer, with additional requirement for mandatory factory production control audits to be carried out by a third party. An assessment by a third party (e.g. EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party. Stage 4: Assessment of the product's conformity When all of the requirements have been established, the conformity of the product to the essential requirements of the norm(s) needs to be assessed. This usually involves assessment and/or testing, and may include an evaluation of the conformity of the product to the harmonised standard(s) identified in step 2. Stage 5: Compile the technical documentation Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product. Technical documentation will usually include: Technical description Drawings, circuit diagrams and photos Bill of materials Specification and, where applicable, EU declaration of conformity for the critical components and materials used Details of any design calculations Test reports and/or assessments Instructions EU declaration of conformity Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA). Stage 6: Make a declaration and affix the CE marking When the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable norms, an EU declaration of conformity must be completed or, for partly completed machinery under the Machinery Directive, an ECU declaration of incorporation. EU declaration of conformity The EU declaration of conformity must include: manufacturer's details (name and address, etc.); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the notified body; and a legally binding signature on behalf of the organization. Product groups The norms (directives and regulations) requiring