NIST SP 951
A Guide to EU Standards and Conformity Assessment
Product Liability
New Approach Directives do not always provide guidance on how to implement, nor do they provide interpretations of the law. Legal critiques of design(s) are conducted in hindsight at trials, where the issue may be whether or not the manufacturer was negligent, and whether or not the designer produced a reasonably safe design. When these are the issues, a national European court will inquire as to how the manufacturer of the product applied (or didn't apply) good safety engineering practices.
A review of the law will show that some designs are deemed "not reasonably safe," and that some manufacturers have judgments rendered against them for failing to exercise reasonable engineering practices. The legal obligation to use good engineering practices in safety matters is not embedded in directives, but exists independently of them.
This does not make design decisions straightforward for the manufacturer, but it does place the manufacturer in a unique position. A manufacturer, or more precisely the designer, is the only one who can evaluate and change the design of a product before it is put on the market. It follows, then, that in the event of a breach of safety, the manufacturer and/or the designer will be the responsible parties required to defend the design decisions related to the product.
The legal concept of product liability is the same in the European Union as it is in the United States, although the scale of award in the United States is considerably higher. Any product manufactured or imported into the European Union which causes damage to individuals or property is covered by the Product Liability Directive (85/374/EEC). This directive provides the right of civil action for product liability to all citizens of the European Union.
The Product Liability Directive covers all moving parts, electricity, raw materials, and components for final products, and holds the manufacturer liable for all damages. If the manufacturer cannot be identified, each supplier of the product becomes liable.
Certain directives require that critical design review processes be documented in writing. In addition, a manufacturer should not consider making a product "safer" for one market than for another.
Manufacturers that place products on the European Union market should reach contractual agreements with customers that include liability issues. In addition to the sales contract, liability aspects should be covered in the Declaration of Conformity, the Technical File, and the User's Manual.
The General Product Safety Directive (92/59/EC) describes the obligations to a manufacturer when no other directive or regulation applies (for example, a wind-powered artistic mobile that is not a machine or a toy). According to this directive (and according to well-established United States law) a manufacturer is expected to consider and deal with the risks involved in the intended use and foreseeable misuse of its products. The scope of this directive includes packaging and instructions. This is not a "CE Marking" directive, and in fact the General Product Safety Directive expressly says that the CE mark is not to be affixed to products that are covered by the directive.
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