By Bill Sullivan

In an environment where the general trend is towards greater business efficiencies - to do more with less – compliance programs, which appear to dilute or divert resources, can sometimes be perceived as unnecessary bureaucracy. In fact they may not only be a legal requirement to trading with certain countries, but could be the key to a golden opportunity.

CE Marking of Products

In order to legally be exported into most countries in Europe, certain products must meet the essential requirements of European Directives. These Directives are legally binding documents, compliance is not an option and cannot be waived by any customer. Products that are subject to the requirements of these Directives are generally those products that have the potential to adversely effect the health and safety of individuals, or have a negative impact on the environment.

The most notable products which are covered by these Directives are machinery of almost any description, pressure vessels, equipment and accessories, electrical and electronic equipment, marine equipment, equipment designed for use in potentially explosive environments and medical equipment.

Routes to Compliance

The actions required to become compliant with the Directives vary according to which Directives apply and also the type or classification of the equipment as defined by the Directives. The requirements of the Directives are essentially to ensure that the responsible body, normally the manufacturer, has identified and addressed all aspects of design and manufacture which could impact safety and the safe operation of the equipment.

Depending on the nature of the equipment or product, the manufacturer may be able to implement and declare compliance without assistance or involvement from an external company. In some cases the Directives require and mandate that the services of a Notified Body be used. A Notified Body is an independent body or company appointed by a governmental agency within one of the European countries or member states, as being capable of performing the duties of a Notified Body as defined by the Directives. These duties may involve design assessment, quality system assessment, verification of tests results and other aspects of the design and manufacturing process depending on the Directive and the type of product or equipment.

Applying the CE Mark and its importance

Compliance with these Directives allows the manufacturer to affix the "CE" mark to the product as an indication of this compliance.

For specific products, compliance with these standards is mandatory in the EU and EFTA countries, and the implications of non-compliance can be severe. Products which are exported to these European countries without being able to demonstrate compliance with required Directives (or existing national standards where the Directives are in their initial "transitional" stage) maybe subject to a variety of actions. A best case scenario would be that the products would be impounded by customs, returned to point of origin outside of Europe (at the manufacturers expense) and/or a fine. A worst case scenario would involve a product which was not declared compliant with the Directives and which caused injury or death to an individual. In this situation, if they have a presence within Europe, the company and the principals in that company, could face enormous fines and possibly jail sentences.

Since the Directives represent the consensus of 18 countries, it can sometimes be difficult to understand not only the intent but also the compliance requirements of the standards. This is compounded by the fact that manufacturers, for the most part, have to make their own determination of which, if any, of the Directives are applicable to the products they export or plan to export to Europe.

Exports to Europe can represent a golden opportunity for North American manufacturers but it is imperative that the requirements of these Directives and CE marking generally are understood so that companies are able to take appropriate actions to ensure compliance.