BSI - helping you through the CE marking process
What is CE marking?
CE marking is a declaration by the manufacturer that the product meets all the appropriate provisions of the relevant legislation implementing certain European Directives. CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking. The initials "CE" do not stand for any specific words but are a declaration by the manufacturer that his product meets the requirements of the applicable European Directive(s).
What are the New Approach Directives?
The European Union introduced a series of measures to simplify the movement of goods throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. New Approach Directives provide controls on product design and above all, seek to harmonize product safety requirements across Europe.
The directives cover a very wide range of product areas including toys, medical devices and pressure equipment. Their primary objective is to ensure that the products are well designed, and safe for the user.
Throughout Europe, where a New Approach Directive is in force, it is necessary for the manufacturer to CE mark their product. CE marking requirements vary from Directive to Directive, and even within Directives.
Third-party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer's unverified claim is all that's asked for. But beware! If you claim your product complies and it doesn't, you will be prosecuted. Where a Directive requires products and/or systems to be independently tested, certified, or inspected, this must be done by a "Notified Body" or "Competent Body".
What is a Notified Body?
A Notified Body is an organization that has been nominated by a member Government and Notified by the European Commission. A Notified Body will be nominated based on designated requirements, such as knowledge, experience, independence and resources to conduct the conformity assessments.
The primary role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE marking. This normally means assessing the manufacturers conformity to the essential requirements listed in each directive. Conformity assessment can be inspection, quality assurance, type examination or design examination, or a combination of these. BSI is a Notified Body for many European Directives.
What are the benefits of CE marking?
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.
Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.
Why choose BSI?
As such BSI has a wealth of experience in helping companies to attain CE marking for their products. Our technical experts are available to help guide you through the process to make it as painless as possible.
What is the Kitemark?
The Kitemark is a voluntary, independent third-party mark that offers peace of mind for both the consumer and the specifier.
To achieve Kitemark certification requires a manufacturer to have a comprehensive quality management system, based on ISO 9001:2000 or recognised factory production control system combined with initial product type testing and regular audit testing. Once achieved the Kitemark can serve as an enhanced marketing tool in a competitive market, by demonstrating an ongoing commitment to quality and safety.
BSI is a Notified Body offering comprehensive services around the world
When applying for a CE mark you need to establish which of the New Approach Directives or older Global Approach Directives applies to your product. CE marking only applies to products within the scope of these Directives. It should not be applied to products if they are outside the scope of the Directives. BSI are a Notified Body for many EU Directives:
Hose and hose reels to control panels, including detectors against BS EN 54 and a range of British European and International standards. Schemes also include domestic, smoke, heat, CO2 and gas alarms.
Covering simple household and work place gloves. All forms of hard hats to sports helmets. Hearing defenders, eye wear, dust protection and breathing apparatus as well as protective suits and work wear. In fact, any product that can be work or used for personal protection.
Any product that has a stored pressure would have to be considered under this Directive and in some cases this could include a complete assmebly or plant. BSI can provide a full range of compliance options for PED including fire extinguishers.
This covers any equipment that is for use within an Explosive Atmosphere, whether it is electrical, electronic or mechanical. Various routes to compliance exist and BSI can help you choose the
best one for your product.
This Regulation covers the assessment, identification an classification of fire risk, explosion or similar events arising from the use of dangerous substances in the workplace.
A wide ranging Directive covering sports equipment to playground equipment – some of which falls under the PPE Directive. As an expert in both, BSI can offer a single assessment that meets both requirements.
BSI’s notification under this Directive is for the safety components that are fitted to lift systems, automatic braking systems, door interlocks and descent braking systems. On site assessments
conducted at the manufacturer’s site or at the lift installation can be arranged.
Applies to passenger carrying vessels where BSI’s notification is for the safety products such as fire, communications and life saving equipment.
Covers all gas appliances and fittings relating to gaseous fuel burning products that are used in lighting, heating and cooking from camping to household equipment.
Low Voltage means all electrical equipment designed for use with a voltage rating of between 50 and 1000 V AC and between 75 and 1500 V DC. The Directive covers consumer and capital goods designed to operate within those voltage limits, including in particular, electrical appliances, lighting equipment (including ballasts), switch gear and control gear, electric wiring, appliance couplers and cord sets, electrical installation equipment and electrical equipment intended for incorporation into other equipment such as transformers and motors.
Defined as weighing instruments that require the action of gravity to determine the mass and require the intervention of an operator during weighing. For instruments designed for domestic or personal use at home, the requirements are simple, only the manufacturers name and the weighing capacity need be marked on the instrument. For commercial, retail and industrial use the requirements are considerably greater.
This Directive relates to products which are produced for incorporation in a permanent manner in works. Works include buildings, roads, bridges and other civil engineering projects.
Covers the energy efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels and forms part of the European Union’s SAVE programme (Specific Actions for Vigorous Energy Efficiency). The Regulations specify minimum levels of efficiency that new hot water boilers, sold in the United Kingdom, must operate at whilst running at full load or part load conditions.
The Directive applies to all active devices and related accessories intended to be permanently implanted in humans. Services include technical documentation/file or design dossier assessment/review, device type examination, product quality assurance (based in ISO 13485), production quality assurance (based in ISO 13485), full quality assurance (ISO 13485), batch verification/release.
The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make a diagnosis of patient medical conditions. Services include technical documentation/file or design dossier assessment/review, device type examination, product quality assurance (based in ISO 13485), production quality assurance (based in ISO 13485), full quality assurance (ISO13485), batch verification/release.
The Directive applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive. Services include technical documentation/file or design dossier assessment/review, device type examination, product quality assurance (based in ISO 13485), production quality assurance (based in ISO 13485), full quality assurance (ISO 13485), batch verification/release.
