by Paul Brooks

To compete in today's global marketplace, U.S. manufacturers are beginning to export more goods to Europe. Before doing so, however, many companies must obtain CE marking, which allows them to move their products freely throughout the European Economic Area. CE marking is required on products that fall within the scope of any of the European Union's 29 New Approach Directives.

"CE" is an abbreviation of the French phrase "Conformité Européenne." CE marking on a product is the manufacturer's assertion that the product complies with the essential/safety requirements of relevant European regulations.

In 1985 the European Union changed its approach toward certification and standards compliance by introducing the New Approach Directives. These established essential requirements and performance levels for specific products. The directives also established "harmonized standards" to which a product must comply and set procedures for assessing products' conformity to relevant essential requirements. The following overview of CE marking covers these requirements in more detail.

The New Approach Directives

With the European Union's consolidation, and to allow for a single approach toward standardization, all member countries are now following the New Approach Directives. Many of the older national regulations, specific to one country, are being replaced by these directives. Currently, manufacturers may place CE marking only on products that comply with the New Approach Directives. Furthermore, all products intended for sale in the European marketplace must comply with any relevant directives once they're voted into law.

The directives cover a wide and growing range of products. As mentioned, CE marking on a particular product is a claim of compliance with a specific directive and any New Approach Directive that might relate to the product. For example, an electromechanical device that incorporates a pressurized vessel might have to comply with the Pressure Equipment Directive, the Machinery Directive and the Low Voltage Directive.

Given the diversity of subjects covered by the New Approach Directives, it's not possible to outline specific actions that will lead to CE marking for your product. These marks mean different things for different products under different directives. However, there are commonalities across most directives.

Essential/safety requirements and standards

Essential/safety requirements are key components of CE marking and the New Approach Directives. The requirements' complexity varies from directive to directive. For example, the essential requirements of the Medical Devices Directive cover devices' safety, risk assessment, physical properties, sterilization, biocompatibility, measuring functions, electrical safety, labeling and instructions for use. The Medical Devices Directive is currently under review.

In order to meet the directives' essential requirements, compliance with harmonized standards is helpful and, in some cases, may be required. Harmonized standards are technical specifications written under a mandate from the European Commission. Once they're accepted as being harmonized, these standards are listed in the Official Journal of the European Union. A harmonized standard offers a presumption of conformity with relevant essential requirements. In other words, when a manufacturer declares that its product meets a harmonized standard, it's presumed that the product meets relevant essential requirements.

It's manufacturers' responsibility to understand how the essential requirements relate to their products and to identify all relevant and appropriate standards.

The manufacturer decides which standards are appropriate for demonstrating conformity with essential requirements. The manufacturer also determines how to demonstrate conformity. To assist in determining applicable standards and how they apply, it's often helpful to perform in-house testing or hire an independent third-party testing group.

For many products, and for some essential requirements, there may be no established standards. In these cases, the manufacturers' own specifications may become the basis for compliance. When using nonharmonized standards, a manufacturer must demonstrate that they effectively address the European Union's essential requirements.

Technical documentation

Having established compliance with essential requirements, the manufacturer must next take steps to ensure the objective evidence is available. Although the content, format and quantity of this documentation will vary from directive to directive, within directives and between product families, technical documentation is critical. For some, the technical documentation's required format is purposely vague to allow manufacturers some flexibility in how they compile and maintain the documentation. For other directives, there are more prescriptive requirements.

Typically, technical documentation includes descriptions of the product and its intended use, product specifications, details of materials, test results and reports, essential requirements checklists, data addressing the directives' requirements, design and manufacturing information, supporting documentation and labels.

Notified bodies

Under all directives, notified bodies play a role in the CE marking process. The notified body is a third-party organization--normally an ISO 9000 registrar, testing body or certification body. Notified bodies receive designation based on demonstrated expertise, experience and competence in assessing product and/or quality systems, as required by the directives. Notified bodies may be obliged to review technical documentation, examine products and/or assess quality management systems' implementation. Under some directives there's very little, if any, notified body involvement; other directives require intense involvement.

Conformity assessment

A manufacturer must follow a conformity assessment procedure in order to place CE-marked products on the market. The company may select from a number of conformity assessment modules, depending on the modules that are permitted or required by the particular directive and the product's perceived risk level. Some products may require a combination of modules, which includes:

A. Internal Control of Production--This encompasses internal production control. For most directives, this module doesn't require notified body involvement. However, for directives such as the Pressure Equipment Directive and noise directives, a derivative called Module A1 does require notified body involvement.

B. EC Type Examination--This includes an examination of the technical documentation and of the product by a notified body and will normally be followed by a module that assesses the production phase. The notified body then issues the EC Type Examination certificate. A similar and related module is B1. EC Design Examination. The processes are the same, but with Module B1, the product's design is evaluated rather than the product itself.

C. Conformity to Type--This covers the production phase and follows Module B. It provides for conformity to type as described in the EC Type Examination certificate issued according to Module B. The notified body is normally required to audit this process.

D. Production Quality Assurance--This details the production phase and may follow Module B. Derived from the quality assurance standard EN ISO 9002, Module D requires the intervention of a notified body, which is responsible for approving and verifying the quality system for production and final product inspection and testing.

E. Product Quality Assurance--This covers the production phase and may follow Module B. It derives from quality assurance standard EN ISO 9003 and requires the intervention of a notified body, which is responsible for approving and verifying the quality system for final product inspection and testing.

F. Product Verification--This occurs at the production phase and may follow Module B. The notified body controls conformity to type (as described in the EC Type Examination certificate or according to the manufacturer's technical documentation) and issues a certificate of conformity.

G. Unit Verification--This concerns the design and production phases. The notified body issues a certificate of conformity for each individual product examined.

H. Full Quality Assurance--Originating from quality assurance standard EN ISO 9001, Module H concerns the design and production phases. A notified body is again responsible for approving and verifying the quality system for design, manufacture, final product inspection and testing as set up by the manufacturer.

Many directives, such as the Toy Directive, rely heavily on Module A, which doesn't require notified body involvement except for products that don't comply wholly with the harmonized standard, which require undergoing a type examination. Other directives, such as the Medical Devices Directive, use the full range of modules, depending on the class of the product. Because the modules are intended to provide templates for conformity assessment, there may be variations in exactly how the individual directives implement them.

Manufacturers' responsibilities

To review, the manufacturer is responsible for identifying which, if any, directives are applicable to its product. If relevant directives are in force, then compliance with the directives' requirements and affixing CE marking for the product will most likely be mandatory.

Under the directives, the manufacturer needs to identify all available conformity assessments required for its product. The manufacturer can then select and choose to follow the most appropriate conformity assessment module, or modules, that fit with its business model.

The manufacturer must also address the directive's essential requirements, identifying and using appropriate standards throughout the process. And the manufacturer's technical documentation must demonstrate compliance with the directive's requirements.

If the directive stipulates that notified body involvement is required, the manufacturer must submit, as appropriate, the quality system, technical documentation and product sample to the notified body for conformity assessment. If the directive indicates that no notified body involvement is required, the manufacturer proceeds using the guidelines given in Module A.

Once a satisfactory conformity assessment is completed, the manufacturer signs a declaration of conformity. This declaration asserts that the product:

n Meets the appropriate directive's requirements

n Has technical documentation available

n Has satisfactorily passed a conformity assessment

The declaration of conformity allows the manufacturer to affix CE marking on the product and prepare to place the product on the market. Careful attention to the declaration must be made because it's considered a crime to falsely prepare a declaration of conformity.

The road to CE marking

Although the New Approach Directives are intended to open European markets to the free movement of goods, national deviations and interpretations may exist, and manufacturers must be aware of them. Therefore, make careful reference to the individual directives that apply to your product(s). Additionally, when CE marking is applied, the manufacturer essentially is claiming that its product complies with national variations of the European directives in countries in which it intends to market the product. Because European countries pass the directives into national laws, attention to these individual variations is critical. For example, if a medical device manufacturer wants to place products on the UK market, it must comply with the UK national regulations, which incorporate the Medical Devices Directive into the UK Consumer Protection Act.

CE marking is still a somewhat daunting and confusing procedure to the uninitiated, but the more you're involved, the clearer it gets. In reality, the directives are incredibly efficient and empower manufacturers to take responsibility for demonstrating their products' and manufacturing systems' compliance, based on the declaration of conformity. If in doubt, always check with your notified body or your consultant. With concerted effort, diligence and time, your product will bear CE marking, and the European marketplace will be open to you.

About the author

Paul Brooks, an expert on CE marking under the Medical Devices Directive, is the head of BSI's Medical Devices Group, a Notified Body. He joined BSI in 1981 and has been working with the company's U.S. subsidiary, BSI Inc., since 1993. Today, he's responsible for BSI's Conformity Assessment Body and IVD Notified Body activities. Letters to the editor regarding this article should be e-mailed to letters@qualitydigest.com.