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by Kevin J. Quinn and Paul Brooks

Sufficiently testing a product to overseas requirements and proving conformity in the new global trade environment can be daunting. Authors Kevin Quinn and Paul Brooks offer a simple overview of the CE Mark and New Approach Directives, and the role they play in introducing your product into the European marketplace.

In 1985 the European Community changed its approach to certification and compliance with standards, by introducing the concept of “New Approach Directives.” These directives establish essential safety or other requirements for specific products or product types and prepared a set of ground rules or procedures for assessing the conformity of products with the relevant essential requirements.

The New Approach Directives

These New Approach Directives cover a wide and growing range of products. The presence of CE Marking on a particular product is not only a claim of compliance with a specific directive, but of compliance with 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 Simple Pressure Vessels Directive, the Machinery Directive and the Low Voltage Directive. Incidentally, CE Marking may only be used to indicate compliance with New Approach Directives, and not with the older technical directives, many of which remain in force.

Because of the diversity of subjects covered by the New Approach Directives, it is not possible to state, simply, that such-and-such an approach will lead to the right to apply CE Marking. In each case, reference must be made to the directive in question for the specific requirements that apply.

Free Movement of Goods

The CE Marking of products is intended to support the free movement of goods within the European Economic Area. All products that bear CE Marking must comply with all provisions of the applicable directives. Where a product carries appropriate CE Marking, the member countries of the European Economic Area must allow the product to be placed on the market.

CE Marking directives now cover many product areas. The current CE Marking directives are:

• Low Voltage Directive 73/23/EEC (amended 93/68/EEC)

• Simple Pressure Vessels 87/404/EEC (amended 90/488/EEC, 93/68/EEC)

• Toys 88/378/EEC (amended 93/68/EEC)

• Construction Products 89/106/EEC (amended 93/68/EEC)

• Electromagnetic Compatibility 89/336/EEC (amended 92/31/EEC, 93/68/EEC, 98/13/EC)

• Machinery 98/37/EC (amended 98/79/EC)

• Personal Protective Equipment 89/686/EEC (amended 93/68/EEC, 93/95/EEC, 96/58/EC)

• Non-Automatic Weighing Instruments 90/384/EEC (amended 93/68/EEC)

• Active Implantable Medical Devices 90/385/EEC (amended 93/68/EEC, 93/42/EEC, 98/79/EC)

• Gas Appliances 90/396/EEC (amended 93/68/EEC)

• Hot Water Boilers 92/42/EEC (amended 93/68/EEC)

• Civil Explosives 93/15/EEC

• Medical Devices 93/42/EEC (amended 93/68/EEC, 98/79/EC)

• Potentially Explosive Atmospheres 94/9/EC

• Recreational Craft 94/25/EC

• Lifts 95/16/EC

• Refrigeration Appliances 96/57/EC

• Pressure Equipment 97/23/EC

• Telecommunications Terminal Equipment 98/13/EC

• In Vitro Diagnostics 98/79/EC

• Radio and Telecommunications Terminal Equipment 99/5/EC

Those new Approach Directives that do not require CE Marking are:

• Packaging and Packaging Waste 94/62/EC

• High Speed Rail Systems 96/48/EC

• Marine Equipment 96/98/EC

Where a new approach directive is relevant and in full force then compliance with the directive is normally mandatory for all relevant products destined to be placed on the European Market.

The bottom line is that CE Marking means different things to different products under different directives. There are, however, fundamentals that are common across most directives.

Essential Requirements and Standards

One of the key components of new approach CE Marking directives are essential requirements. Meeting these requirements is fundamental to meeting the relevant directive and being able to place the product on the European market with CE Marking. The extensiveness of the requirements will vary from directive to directive. For the Medical Devices Directive, debatably one of the most comprehensive new directives, the essential requirements cover, for example, safety of the device, risk assessment, physical properties, sterilization, bio-compatibility, measuring functions, electrical safety, labeling, and instructions for use.

Key to meeting essential requirements are the standards, compliance with which demonstrates how the essential requirements have been met. Harmonized standards are standards that have been written normally under a mandate from the European Commission, which specifically address essential requirements. A standard that has been accepted as being harmonized will have been listed in the Official Journal (OJ) of the European Union.

Manufacturers have a responsibility to understand how the essential requirements relate to their products and identify all relevant and appropriate standards. Once the standards have been identified, the manufacturer decides which ones will be used to demonstrate conformity with essential requirements and how this will be achieved; perhaps commissioning independent third party testing or in-house testing would be practical.

For many products, and for some essential requirements, there may not be established standards and in this case the manufacturer’s own specifications may become the basis of compliance. In all cases, and particularly when utilizing non-harmonized standards, the manufacturer must be able to demonstrate that selected standards effectively address the essential requirements. The benefit of utilizing harmonized standards is that there is a presumption of conformity with the relevant essential requirements; this means that where a product satisfies the harmonized standard it is also presumed to meet the essential requirements that have been identified, normally within the standard.

Technical Documentation

Having established the compliance with essential requirements, the manufacturer needs to take steps to ensure that the objective evidence is available. The need for technical documentation is core to the directives, although the content, format and quantity of this documentation will vary enormously from directive to directive and, within directives, from product family to product family. The format of technical documentation was deliberately left vague in some directives to allow manufacturers some flexibility in how they compiled and maintained documentation to demonstrate conformity. For other directives there are more prescriptive requirements.

Typically technical documentation includes a description of the product and its intended use, product specifications, materials details, test results and reports, essential requirements check-lists, data addressing the directives requirements, design and manufacturing information, supporting documentation, and labels.

Notified Bodies

Under some directives there is a role for a notified body in the CE Marking process. The notified body is a third party organization, normally an ISO 9000 registrar, i.e., BSI (British Standards Institution) or certification body, which has been formally designated under the directive as a Notified Body. The Notified Body will have received designation based on expertise, experience and competence that can be demonstrated to assess product and/or quality systems as required by the directives. Notified Bodies may be required to review technical documentation, examine products and or assess the implementation of quality management systems.

Under some directives there is very little, if any, Notified Body involvement; other directives require intense Notified Body involvement.

Conformity Assessment

Conformity assessment is the procedure the manufacturer follows to place CE Marked products on the market. A select number of conformity assessment modules exist that the manufacturer may select from depending on the modules permitted or required by the particular directive and the classification or level of risk that is perceived with the product. Some products may require a combination of modules.

The modules are:

A: Internal Control of Production —Covers internal design and production control. This module does not require Notified Body involvement.

B: EC Type Examination—Covers the design phase, and must be followed up by a module providing for the assessment of the production phase. A Notified Body issues the EC Type Examination certificate.

C: Conformity to Type—Covers the production phase and follows module B. Provides for conformity with type as described in the EC Type Examination certificate issued according to module B. This module does not require a Notified Body to take action.

D: Production Quality Assurance —Covers the production phase and follows module B. Derives from quality assurance standard EN ISO 9002, with the intervention of a Notified Body responsible for approving and controlling the quality system for production, final product inspection, and testing set up by the manufacturer.

E: Product Quality Assurance—Covers the production phase and follows module B. Derives from quality assurance standard EN ISO 9003, with the intervention of a Notified Body responsible for approving and controlling the quality system for final product inspection and testing set up by the manufacturer.

F: Product Verification—Covers the production phase and follows module B. The Notified Body controls conformity to type as described in the EC Type Examination certificate issued according to module B, and issues a Certificate of Conformity.

G: Unit Verification—Covers the design and production phases. Each individual product is examined by a Notified Body, which issues a Certificate of Conformity.

H: Full Quality Assurance—Covers the design and production phases, originating from quality assurance standard EN ISO 9001, with the intervention of a Notified Body responsible for approving and controlling the quality system for design, manufacture, final product inspection, and testing set up by the manufacturer.

Many directives, such as the Toy Directive, rely heavily on Module A, which requires no Notified Body involvement. Other directives, such as the Medical Devices Directive, utilize the full range of modules depending on the class of the medical devices in question. The modules are intended to provide the model for conformity assessment, but there may be variations in exactly how the individual directives implement them.

The Route to CE Marking

The manufacturer must identify which, if any, directives are applicable to the product. If there are relevant directives and they are in force, then compliance with the requirements of the directive and the CE Marking of the product is likely to be mandatory.

If a directive instructs the manufacturer to identify whether a different conformity assessment module to the product in question is available, does the directive have any classification requirements that affect the conformity assessment modules which are applicable? An appropriate conformity assessment module (or combination of modules) must be selected and followed.

The manufacturer will need to address the essential requirements of the directive, identifying and utilizing appropriate standards throughout the process. Compliance with the requirements of the directive must be verified in the manufacturer’s technical documentation.

If the directive identifies that Notified Body involvement is required, the manufacturer must submit as appropriate: the quality system, technical documentation, and some product to the Notified Body for conformity assessment. If the directive indicates no Notified Body involvement is required, the manufacturer proceeds under Module A.

Once a satisfactory conformity assessment is completed, the manufacturer signs a declaration of conformity, which is the manufacturer’s claim that the product meets the directive’s requirements, that the technical documentation is available and that a conformity assessment has been satisfactorily completed. This declaration of conformity allows the manufacturer to affix CE Marking on the product and prepare to place the product on the market. Careful with this one—it is considered a crime to falsely prepare a Declaration of Conformity. In the United Kingdom, the Queen still reigns over most laws; it is believed that she can order you to be beheaded for such a crime!

Conclusions

This article has attempted to simplify CE Marking, and while the concepts and procedures identified are generally accurate, the directives are implemented with deviations that need to be understood, therefore, it is important that reference be made to the individual directives. It is also important to understand that when CE Marking is applied, the manufacturer is claiming compliance not with the European directive, but with individual interpretations of the directives that have been passed into the national laws within the individual European countries. Better stated, if a medical device manufacturer wants to place products on the U.K. market then they must comply with the U.K. national regulations, which have transposed the Medical Devices Directives into U.K. law.

The new CE Marking New Approach Directives were intended to open European markets to the free movement of goods, but manufacturers must still be aware of national deviations and interpretations that may exist. CE Marking is still a somewhat daunting and confusing procedure to the uninitiated, but the more you are involved the clearer it gets. In reality the directives are incredibly efficient and empower manufacturers to take responsibility for demonstrating the compliance of their products and manufacturing systems, based on the declaration of conformity. If in doubt always be sure to check with your Notified Body or your Consultant.

Eventually it all makes sense, we promise! //

Copyright 2000, ASTM

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Kevin J. Quinn is the west coast business development manager and BSI Notified Body representative for BSI, Inc., based in San Diego, Calif. He worked in the medical industry in sales and management positions for over 10 years prior to joining BSI Inc. Quinn can be contacted at 619/216-9180.

Paul Brooks is head of Notified Body, Medical Devices. He joined BSI in 1981 and has worked for BSI for over 20 years. In 1993 Brooks joined BSI Inc., the U.S. subsidiary of BSI, as the local expert on CE Marking under the Medical Devices Directive. Today, he is responsible for BSI's Conformity Assessment Body and IVD Notified Body activities and he is based in BSI headquarters in the U.K. Brooks can be contacted in London at 011-44-20-8996-
9000.