By Bill Sullivan

The CE Mark is a mark that is placed on a product, usually by the manufacturer, that is a visual identifier that the product meets all of the requirements of one or more European Directives.

What is a European Directive ?

In order to facilitate free trade within the European Economic Area (EEA) and to ensure the safety of certain products, the European Commission have developed a series of Directives, which can be likened to standards. Most of the Directives are "vertical" that is they are product type specific – the Machinery Directive, the Pressure Equipment Directive, the Medical device Directive etc. Some Directives are "horizontal" that is they may apply to multiple product type or equipment – the Low Voltage Directive, the Electro Magnetic Compatibility Directive and others. The Directives themselves generally do not contain specific technical requirements which you might normally expect to find in a typical standard. Instead most of them have a list of Essential Requirements which tend to be generic in nature. Compliance with Essential Requirements is most effectively achieved by using separate technical standards which do spell out specifically how to be compliant with the Essential Requirements. These technical standards and referred to Harmonized Standards.

In order to be legally exported into or between most countries in Europe, certain products must meet the Essential Requirements of one or more of these European Directives. The Directives are legally binding documents, compliance is not an option and cannot be waived by a customer or by contract amendment. 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 domestic animals, or that may have a potentially negative impact on the environment.

Which countries have adopted the Directives ?

The Directives have been adopted by all the member states (countries) of EEA.

The EEA members are Iceland, Liechtenstein and Norway together with all EU member states in the European Union - Germany, France, UK, Italy, Netherlands, Spain, Denmark, Belgium, Ireland, Portugal, Greece, Luxembourg, Austria, Bulgaria, Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovak Republic, Slovenia, Finland, Sweden and member states in the European Free Trade Association -Norway, Iceland and Liechtenstein (Sweden, Austria and Finland are members of both the EU and EFTA). So EEA = EU + EFTA. It is highly likely that the Directives will be adopted by other non-EFTA European countries (specifically some Baltic countries) and countries outside of Europe in the coming years.

What products are covered by the Directives ?

The Directives apply to a wide range of different products. Some of the most notable products which are covered by these Directives are machinery of almost any description, pressure vessels, pressure equipment and pressure accessories, electrical and electronic equipment, marine equipment, equipment designed for use in potentially explosive environments, medical equipment and personal protective equipment.

Do the Directives apply to my products ?

There are some exclusions but if you manufacture any of the above types of equipment or products and export or plan to export to Europe, then one or more of the Directives probably applies.

If the Directives do apply what do I have to do ?

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. For most products the manufacturer will have compliance route options. Most of the Directives will have a compliance option which will involve utlilizing an established quality system such as ISO 9001 or 9002 along with supplemental requirements. The Essential Requirements of the Directives are designed 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 and affix the CE mark to his products without assistance or involvement from an external company. In some cases however the Directives require and mandate that the services of a Notified Body be used.

What is a Notified Body ?

A Notified Body is an independent body or company appointed by a governmental agency within one of the EEA 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.

Compliance with these standards is mandatory in EEA member states. 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 (at the manufacturers expense) and or a fine. A worst case scenario would involve a product which was covered by one of more of the Directives, was not declared (CE marked) as compliant with the Directives and which caused injury or death to an individual. In this situation, if the company had a direct 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. The presence of a CE mark on a product can never eliminate legal action in case of product failure but it can mitigate exposure for law suites based on negligence.

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. It makes good business sense and it’s a legal requirement.