LVD Directive 2014/35/EU has been issued as part of a large upgrade of CE Marking Directives to include EMC, LVD and RED (Formerly R&TTE).
2014 /35/EU has replaced 2006/95/EC in April 2016.
The changes to the Directive are mainly procedural rather than technical so the areas mostly effected are documentation and labelling.
There are some changes in the scope of the Directive.
An importer or distributor is considered to be a manufacturer if he places the equipment on the market in his own name or modifies the equipment in such a way that compliance with the Directive may be affected.
- A product label showing a Manufacturers name / trade mark AND address is required.
- A product label showing an Importers name / trade mark and address is required.
- A product label showing a type, batch or serial number is required, this should also appear on the Declaration of Conformity to aid traceability.
Instructions for Use must be provided with the equipment.
Technical Documentation must be held and be available for examination by – the manufacturer, an authorised representative or an importer, to include:
- A general description of the apparatus.
- Conceptual design and manufacturing drawings and schematics of components, sub-assemblies, circuits, etc.
- A list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of the Directive. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied.
- Results of design calculations made, examinations carried out, etc.
- Test Reports.
A Declaration of Conformity (D of C) must be raised by the manufacturer or an Authorised Representative (who has a formal written mandate from the manufacturer to do so).
The (D of C) shall be kept for at-least 10 years from the date of placing the product on the market.
Compliance to more than 1 Directive shall be shown on a single D of C with references to the appropriate Directives and Standards.
A D of C shall not be made to more than 1 Directive if this is not appropriate (e.g. LVD and RED).