CE marking is required for products for which a CE marking directive or regulation has been adopted. Products that are not covered by the European CE marking directives may fall within the scope of other European or national legislation. If there is no specific legislation, the General Product Safety Directive (2001/95/EC) applies. This European Directives requires that products are safe, but it does not require any marking.
Under EU rules certain products are subject harmonised technical requirements. Generally the legislation is limited to the essential requirements usually in terms of performance and function rather than being prescriptive as to how exactly the standards are met. The technical specifications for products meeting the essential requirements are set out in legislation and publish standards
Products manufactured in compliance with this standard benefit from a presumption of conformity with the corresponding essential requirements in the legislation.There are provisions for conformity assessment which in many cases is by way of manufacturers declaration
h legislation applies to the marketing and sale of products. Products must comply with the requirements at that time. It applies to manufacturers and importers into the EU. Intra-EU distributors have less onerous duties.
The manufacturer is responsible for conformity assessment and has obligations in relation to traceability. It has a duty to have required technical documentation and an EU declaration of conformity. Some information is required to accompany, The product instructions and safety information is usually required by the particular legislation in language that can be understood by end-users. The technical documentation must be kept and maintained together with arrangements for tracing such as numbered batches product serial numbers et cetera
It must indicate its name trademark addresses and fix the CE conformity marking in accordance with applicable legislation . In some cases it must certify the product and/or the quality system.
It has obligations to take steps when nonconformity comes to its attention. It must cooperate with authorities required technical documentation must be retained for a period generally 10 years.EU legislation recognises harmonised standards adopted by bodies. There are provisions for the recognition of European standards adopted by the European standards organisations
Harmonised standards may be voluntary although recognised by EU regulation. In this case, the standard does not give a presumption of conformity with essential requirements. There are procedures for the adoption of harmonised standards involving consultation and participation of interested parties. There is EU legislation which provides for a framework of formal adaptation of standards this involves a number of procedures, consultation, drafting enquiries et cetera