New EU Legislative Framework, CE-Marking and Technical File Management
New EU Legislative Framework, CE-Marking and Technical File Management
A new legislative framework EC Regulation 765/2008 for the marketing of consumer products came into effect in January 2010 across EU Member States. It issupported by Commission Decision 768/2008/EC and collectively is known as RAMS' Regulation on Accreditation and Market Surveillance. These EU laws have a very wide scope and are of major importance to the movement of products within the EU.
RAMS is binding on EU Member States and provides a common framework for market surveillance, accreditation of test houses, rules for CE-marking and the control of products imported from third countries. The laws impose specific importer obligations for checking the conformity of products with EU Directives such as the Low Voltage Directive 2006/95/EC for electrical products. Customs at port of entry have more powers. Own-brand products must include certain information on packaging for traceability. Sample testing must take place and technical files must be reviewed and continuously updated, preferably with a supporting ce marking software system or process.
The latest Machinery Directive takes account of the new legislative framework and its impact can be seen in the new EU Toy Safety Directive 2009/48/EC. The new directive substantially amends the previous Toy Safety Directive 88/378/EEC with clear reference to the obligations for manufacturer and importers. There is a significantemphasis on technical file documentation as a means of demonstrating compliance. Indeed, a formal non-compliance may be raised if the EC Declaration has not been drawn up correctly or if the technical file documentation is either not available or not complete.