We help organisations and brands to produce documentation according to legal requirements

Would you like to have your manual analysed to make sure it conforms to the relevant legislation? Or are you looking for a partner to develop your documentation according to international standards and legislation? INSTRKTIV can take care of this. We offer various kinds of advice and support in the development of your documentation, such as legislation checks or developing the full documentation according to European or international legal requirements. 


New Legislative Framework

The starting point for the CE label is the New Legislative Framework. These impose core requirements in health, safety, the environment, and consumer protection on products that are traded within the European Economic Area (EER). The entity that brings the product to market within the EU’s borders is responsible for conforming to the requirements of the  New Legislative Framework.

The European New Legislative Framework Directives impose requirements on products in various categories. Thus there are directives for low-voltage appliances and toys, but also for machines, telecommunications equipment, and electrical products that could potentially cause and outage. Manuals—or, rather, instructions—are treated extensively in the directives, and must also meet minimum requirements. Should a product not fall under a given requirement, then the General Product Safety Directive, 2001/95/EC, which deals general product safety, is applicable. This regulation states that “manufacturers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks.” In accordance with the law on liability for defective products, manufacturers are liable for damage caused by defects in their products. And a product can also be deemed defective if the manual has defects.

New Legislative Framework - check user manual

Harmonised Standards

To comply with the requirements as set out in the directives, one can use standards. At the European level, harmonised standards have been developed. These describe how the requirements in the directives can be implemented, and offer specific guidelines for doing this. Thus the directive might indicate, for instance, that the instructions should provide information on the safe use of the product. The standard then describes, for a given product, how this can be interpreted. For instance, for most products that have hot surfaces, the standard stipulates that a symbol to that effect has to be placed on the product and that its meaning has to be explained in the manual. If the standards are applied by a manufacturer (this is not mandatory), a number of benefits result, such as the following: 

  • The latest safety techniques are applied.
  • The directives are made more concrete.
  • Presumption of conformity is created.
  • A maximum legal burden of proof is built up.

Internation Law

In cases where a product is being brought to market internationally, the legislation in the destination country must be taken into account. In the United States, for instance, the rules on health and safety are promulgated by the various federal agencies such as the Occupational Safety and Health Administrationn (OSHA), the main federal agency charged with the enforcement of health and safety legislation, or the Consumer Product Safety Commission. These agencies approve standards as well as testing facilities. Approved standards are therefore part of federal law and must be followed.

When it comes to exporting to the US, it may be that a product has to be tested by a testing facility such as FM Global or UL. OSHA has a rule that electrical equipment must be tested and approved according to an applicable norm such as NFPA, the National Electrical Code from the National Fire Protection Association.

In Europe we have the Directive 85/374/EEC - liability for defective products, under which the manufacturer is liable for any product defects. In US jurisprudence, manufacturers are obliged to warn of dangers that may be associated with the use or maintenance of their products. That explains what we see as the often excessive presence of warnings on products. 

How can we help you?

Are you feeling uncertain about your manual and whether it meets the requirements of the relevant directives? Would you like to have your manual checked and upgraded as needed? We’ll be happy to take care of this for you.

Here’s what you can expect:

  • An overview of the directives that your product must be in conformity with
  • An overview of harmonised standards, in order to meet the requirements of these directives
  • An analysis of your manual for conformity with these standards and directives
  • An analysis of your manual on the basis of EN-IEC 820791 or the ANSI Z535.6
  • Practical tips for upgrading your manual, or delivery of your manual upgraded to conform with the relevant requirements

Keen to find out how we can help you?
Ask us for a quote.

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