New products sold in the EU and other regions of the world often need to undergo some form of type approval or other form of product certification. Product certification marks vary depending upon where the product is destined to be sold in the EU the product is required to carry the CE mark. In many cases the manufacturer of the product is required to create a technical construction file which contains sufficient information to prove that a product complies with the relevant European directive, or European directives. EU directives are transposed into law in member states of the EU and therefore it is mandatory that the key requirement of any applicable CE marking directive is adhered to.
CE mark requirements will vary depending on product type but in most cases a product will be required to comply with at least one relevant standard. There are basically two types of standard: harmonised and non-harmonised. The difference between the two is that a harmonised standard has been adopted by the European Union and listed within the official journal. Standards listed within the official journal (often referred to as the OJ) mean that if a product complies with the standard there is a presumption of conformity with the relevant directive. Non-harmonised standards do not have the luxury of a presumption of conformity therefore a manufacturer must be more thorough in collating information when using another type of standard. The manufacturer must ensure that whatever standards are used there is sufficient evidence to prove compliance with the mandatory parts of any associated directive.
Which standards are used to prove compliance is voluntary however most manufacturers will where one exists follow the requirements of a harmonised standard. Perhaps the product is cutting edge and there is no harmonised standard to cover a new type of product. In this case if a manufacturer chooses to use a non-harmonised standard then there are a number of generic standards that can be used to prove compliance with product safety. The product specific standard needs to be chosen carefully to ensure that the collated information within the technical file is sufficient to prove due diligence and product compliance.
For certain types of product the use of a third party organisation is a requirement of a directive particularly if the product is potentially dangerous in use. In this case the directive may require the manufacturer to employ the services of a notified body. In certain cases use of a notified body is also mandatory where no harmonised standards currently exist.
The technical file should contain sufficient information on components making up the product, product design calculations, product testing, user instructions, and labelling and other relevant information to prove that the product can be safely used. The manufacturer may also be required to create a declaration of conformity which may need to be provided to the end user as part of the documentation supplied with the product.
CTI-CEM International notified body number 1942 are experts in many product areas and can check if documentation is sufficient and issue third party certification as a notified body where it believes a product is complaint with a relevant directive.
CTI-CEM can if required organise testing through our parent company as part of product certification. Samples can be tested at our internationally accredited test laboratory. Our laboratory can examine a prototype as the product certification sample.
It is the aim of CTI-CEM to make the process of product certifications, approvals and release to market, easier, safer, and faster.
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