CE Certification India Practical Guide for Exporters and Manufacturers

1 Introduction
2 CE marking and the European market
3 Products commonly subject to CE marking
4 Conformity assessment process
5 Authorised representatives and importers
6 Notified bodies
7 Common compliance problems
8 Establishing a sustainable compliance process
9 Related articles on Designing Buildings

[edit] Introduction

CE marking is a conformity marking used for products placed on the market in the European Union (EU) and European Economic Area (EEA) where EU harmonisation legislation requires it. It indicates that the manufacturer has declared conformity with the applicable EU requirements. CE marking is not, in general, a certification issued by a central European authority, and the conformity assessment process varies according to the product and the legislation that applies.

For Indian manufacturers and exporters, understanding the applicable EU product legislation is an important part of supplying products to European markets. Requirements can apply to electrical and electronic equipment, machinery, medical devices, personal protective equipment, construction products, pressure equipment, radio equipment and various other product categories. The applicable requirements depend on the nature and intended use of the product.

[edit] CE marking and the European market

CE marking is required for products within the scope of specific EU harmonisation legislation where the legislation requires the mark. It is not a general requirement for every product sold in Europe. Products outside the scope of CE-marking legislation must not normally bear the CE marking simply because they are intended for sale in the EU.

The EEA comprises the EU member states together with Iceland, Liechtenstein and Norway. CE marking is also recognised under certain arrangements in other European markets and territories. The relevant legislation should therefore be established before determining the conformity assessment procedure.

CE marking should not be confused with a voluntary quality mark or a general indication that a product has been independently certified. In many cases, the manufacturer can assess conformity itself. Where EU legislation specifies a mandatory third-party conformity assessment procedure, an appropriately designated notified body must be involved.

[edit] Products commonly subject to CE marking

Indian manufacturers may encounter CE-marking requirements when exporting a wide range of products. Examples include machinery, electrical and electronic equipment, medical devices, personal protective equipment, radio equipment, pressure equipment and certain construction products.

A product may be subject to more than one piece of EU harmonisation legislation. For example, electrical or electronic equipment may need to comply with requirements concerning electromagnetic compatibility, electrical safety and restriction of hazardous substances, depending on its characteristics and intended use. The first stage is therefore to identify the legislation applicable to the particular product rather than selecting a generic certification procedure.

Construction products are subject to specific rules. Under the EU Construction Products Regulation, CE marking may be required where a product is covered by a harmonised technical specification or an applicable European Technical Assessment. The requirements for construction products differ in important respects from those applying to other CE-marked products.

[edit] Conformity assessment process

[edit] Regulatory and product assessment

The process normally begins by establishing which EU legislation applies to the product and determining the applicable essential health, safety, environmental or performance requirements. The manufacturer should also identify the conformity assessment procedure specified by that legislation and determine whether harmonised European standards can be used to demonstrate conformity.

Compliance with Indian legislation or standards does not by itself establish compliance with EU requirements. Indian standards may provide useful technical evidence, particularly where they are based on international or European standards, but the manufacturer must demonstrate conformity with the specific requirements applicable to the EU market.

[edit] Risk assessment, testing and technical documentation

A risk assessment is an important part of the conformity assessment process for many types of product. It should consider the intended use, reasonably foreseeable misuse and relevant hazards throughout the product's lifecycle. The precise requirements depend on the legislation applicable to the product.

Testing may be required to demonstrate compliance with applicable requirements. Harmonised European standards can provide recognised methods for demonstrating conformity where they are relevant to the product and legislation. Testing may be undertaken in India or elsewhere, provided that the resulting evidence is suitable for the applicable conformity assessment procedure.

The manufacturer must compile technical documentation demonstrating how the product complies with the applicable requirements. Depending on the product, this may include product descriptions, design and manufacturing information, drawings, calculations, risk assessments, test reports, standards applied and details of the conformity assessment procedure. The documentation must be kept available for the period specified by the applicable legislation.

[edit] Declaration of Conformity and CE marking

Where required by the applicable legislation, the manufacturer draws up an EU Declaration of Conformity. This identifies the product and manufacturer and states the EU legislation with which the product complies. It also identifies relevant standards or other technical specifications and, where applicable, details of the notified body involved in conformity assessment.

The manufacturer is responsible for ensuring that the declaration is accurate and that the product remains compliant. Once the applicable conformity assessment procedure has been completed, the CE marking can be affixed in accordance with the relevant rules. Where a notified body is involved in a conformity assessment procedure, its four-digit identification number may need to accompany the CE marking.

CE marking is therefore normally the final indication of a conformity assessment process rather than a certificate issued by an organisation called a 'CE certification authority'.

[edit] Authorised representatives and importers

The appointment of an authorised representative in the EU is not a universal requirement for every CE-marked product. The requirement depends on the applicable EU legislation. Some product legislation requires or permits a manufacturer established outside the EU to appoint an authorised representative, while other legislation imposes responsibilities on importers or other economic operators.

Where an authorised representative is required or appointed, the representative acts within the scope of the manufacturer's written mandate and can have specified obligations relating to technical documentation, declarations of conformity and cooperation with market surveillance authorities. The representative's name and address may need to appear on the product, packaging or accompanying documentation where required by the relevant legislation.

An Indian manufacturer should therefore establish the economic-operator requirements for its particular product before exporting. These may involve an authorised representative, importer, fulfilment provider or another responsible economic operator within the EU.

[edit] Notified bodies

Some EU product legislation requires conformity assessment by a notified body. A notified body is an organisation designated by an EU member state to carry out specified conformity assessment activities under particular EU legislation. The body must be notified for the relevant legislation and scope; a laboratory or certification organisation is not automatically a notified body for all CE-marking purposes.

Where third-party assessment is mandatory, the notified body may examine technical documentation, assess the product, conduct or oversee testing, inspect product ion facilities or perform other activities specified by the applicable conformity assessment procedure. The exact role depends on the product and legislation.

Determining at an early stage whether a notified body is required is important because it can affect the design, testing, documentation, production controls and timescale for placing the product on the EU market.

[edit] Common compliance problems

[edit] Misidentifying applicable legislation

A common problem is identifying only the most obvious piece of EU legislation when a product is actually subject to several requirements. The manufacturer should assess the complete product and its intended use before deciding which conformity assessment procedures apply.

[edit] Incomplete technical documentation

Technical documentation should provide evidence that the product complies with all applicable requirements. Missing test reports, incomplete design information, inadequate risk assessments or failure to document changes can make it difficult to demonstrate conformity if requested by a market surveillance authority.

[edit] Failure to review changes

Changes to components, software, materials, manufacturing processes or product design can affect conformity. Technical documentation and the Declaration of Conformity should therefore be reviewed when significant changes are made. Additional testing or a new conformity assessment may be necessary where the changes affect the applicable requirements.

[edit] Treating CE marking as a one-off certification

CE marking is an ongoing responsibility rather than a one-time certificate. The manufacturer remains responsible for maintaining conformity throughout production and for ensuring that technical documentation and declarations remain accurate. Applicable EU legislation and standards can also change, requiring products and compliance procedures to be reviewed.

[edit] Establishing a sustainable compliance process

For Indian manufacturers exporting regularly to the EU, conformity assessment is most effectively incorporated into product development and manufacturing processes rather than treated as a separate activity immediately before export. Regulatory reviews, risk assessment, standards selection, testing, technical documentation and change control can be incorporated into established design and quality procedures.

Manufacturers should also distinguish between mandatory legal requirements and voluntary certification or quality schemes. Additional certification may provide commercial or technical benefits, but it does not replace the manufacturer's responsibility to comply with applicable EU legislation or, where required, to use a notified body.

A systematic approach can reduce the risk of non-compliant products being prevented from being placed on the market, subject to corrective measures or withdrawn following market surveillance.