Measuring instruments MID. Non-automatic weighing instruments NAWI. Cableway installations designed to carry persons. Gas appliances GAD. Inspection of pesticide application equipment. Machinery MD.
Pressure equipment PED. Rail system: interoperability. Recreational craft and personal watercraft. Community postal services. Packaging and packaging waste. The EC Declaration of Conformity and CE mark are valid as long as your product meets the applicable health, safety, and environmental requirements of the directive s. If you have changes in product design or characteristics, you may have to have the product or component tested to ensure it is still in compliance with the appropriate directive.
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Share Facebook. The essential requirements that products have to fulfil, for example safety, are created at EU level and are set out in general terms in these directives. Harmonised European standards are issued with reference to the applied directives and express the essential safety requirements in detailed technical terms. It is up to you to ensure that your product complies with the essential requirements of the relevant EU legislation.
The use of harmonised standards remains voluntary. You may decide to choose other ways to fulfil these essential requirements. Each directive covering your product specifies whether an authorised third party Notified Body must be involved in the conformity assessment procedure necessary for CE marking.
This is not obligatory for all products, so it is important to check whether the involvement of a Notified Body is required. UK conformity assessment bodies can no longer carry out mandatory conformity assessment for products being placed on the EU market. If you manufacture a product it is your responsibility to test the product and check its conformity to the EU legislation conformity assessment procedure.
One part of the procedure is, as a general rule, a risk assessment. By applying the relevant harmonised European standards, you will be able to fulfil the essential legislative requirements of the directives. You must be able to present the technical documentation and EC DoC to the relevant national authorities, if requested. The CE marking must be placed on the product by the manufacturer, or by his authorised representative within the EEA or Turkey.
It must be placed according to its legal format to the product or its data plate. It must be visible, legible and impossible to remove. If a Notified Body was involved in the production control phase, its identification number must also be displayed. Once you have satisfied the conformity assessment requirements for CE marking you must attach the CE marking to your product or its packaging. There are specific rules for using the CE marking for your product, as well as rules for the reproduction of the CE marking logo.
In general you should attach the CE marking to the product itself but it may also be placed on the packaging, in manuals and on other supporting literature. Rules covering the use of the CE markings vary depending on the specific EU directive that applies to the product and it is advisable to study the applicable guidance. The following general rules all apply:. Member states will ensure they implement the regime governing the CE marking.
Is the CE Marking required to sell a product? If the components are CE certifiied, does the overall device also need certification? As a general rule, it is the party responsible for the design and manufacture of a product. It is impossible to give a generic response to this question as it depends on the product and the applicable directives.
Some directives only deal with products that are "Simple pressure vessels", while others such as the Construction Products Directive or the Low Voltage Directive cover incomplete products. In addition, the Machinery Directive establishes a number of different procedures depending on whether it is a machine, a safety component, an unfinished machine or one that will be incorporated into another.
If a worn or defective part is being replaced for an identical one i. However, when this change implies a significant modification of the complex device, affecting compliance with arequirement of the directive, the party responsible for the modification will assume responsibility for compliance of the device with the applicable directives.
It is firstly important to distinguish between products being put on the market which are made by a manufacturer inside or outside the European Union EU. If the product is made by a non-EU manufacturer, the person who commercialises the device in the EU assumes all the responsibilities which would normally fall on the manufacturer or their authorised representative and, therefore, must ensure that the product complies with the essential requirements and submit all the relevant documentation for control purposes, should this be necessary.
If it is made by an EU manufacturer, this system does not apply and responsibility may not be passed to a third party distributor, user, etc. This also applies when an authorised EU agent is involved.
What is CE Marking? What does CE Marking mean? What products need the CE Marking? Manufacturers need to establish: What countries they want the product to be introduced in to.
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