The ce marking represents a manufacturers declaration that products comply. Assessment of compliance of the product with the requirements relating. This website uses cookies so that we can provide you with the best user experience possible. Below is an example of a european declaration of conformity and an example form for a declaration of conformity. Most ce directives and regulations have different requirements for the content of the declaration of conformity. A ce declaration of conformity also called a ce certificate, ec declaration of conformity or eu declaration of conformity is the document that shows that the product complies with the applicable legislation.
Its just a document that you sign to congratulate yourself of the great job you have done and to swear that you have respected all the laws. I know when you read, the requirements, this looks easy. Declaration of conformity doc we, libelium comunicaciones distribuidas s. Ec declaration of conformity for the following equipment. This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations. Radio equipment directive 201453eu ecodesign directive 2009125ec regulation ec no. Gsm40ax x05,07,09,12,15,18,24,48, gsm60ax x05,07,09,12,15,18,24,48 is herewith confirmed to comply with the requirements set out. Manufacturers declaration of conformity for all ansell electrical products in accordance with ce mark ansell lighting declares that all products have been fully designed, manufactured and tested in accordance with the requirements of relevant legislation. The publication and the copy of the contents, even a part, in. The eu declaration of conformity which is the most common term used in ce marking is a document confirming that the product is placed in the market in accordance with the relevant product legislation. This is, if i may say, a pillar on the medical device regulation process. Is identical to the ppe which is subject of ec type. Ce marking legislation lvd low voltage directive 201435eu.
Kensington computer products group, a division of acco brands, inc. Last two digits of the year in which the ce marking was affixed. As a senior official of the manufacturer, having responsibility for the regulatory compliance of the medical device with the requirements of the canadian medical devices regulations and this declaration of conformity, i hereby declare that the information i have provided in support of the safety and effectiveness of the medical device to be. The conformity assessment procedure as detailed in annex iii has been applied with the involvement of a notified body for assessment against articles. Ind1002371 declaration of conformity we, manufacturer, hatteland technology as, eikeskogvegen 52, n5570 aksdal, norway declare under our sole responsibility that the jh mmd, jh mmc, jh std, jh mil, hm nmd, hm mil, hm cmd, ht std, hd mmd, hm mmd, hm xrd, hm rmd. It is a legal document that is mandatory for products that fall within the scope of ce marking. A declaration of conformity is a document stating that a product, usually electronic, meets the standards to which it must legally adhere, such as safety. Declare under our sole responsibility that our product and in combination with. By drawing up and signing the ce declaration of conformity, the manufacturer becomes responsible for the conformity of the product. The ce marking on a dell product indicates conformity to the provisions of applicable european union eu directives. Tussendiepen 4, 9206 ad drachten, the netherlands address adresse declare under our. The declaration shall be in respect of all community acts applicable to the.
Radio equipment directive 201453eu red rohs2 directive 201165eu the conformity assessment procedure used for this declaration is annex iii of red 201453eu and the product will bear the cemarking ce accordingly. Ce declaration of conformity compliance engineering. Ce declaration of conformity derekduck industry corp. We hereby declare under our sole responsibility that the following apparatus. The undersigned hereby declares that the above reference products to which this declaration relates is in conformity with the provisions of. The ce marking is the manufacturers declaration that the product meets the requirements of the applicable ec directives. Galway, ireland declare under our sole responsibility that the products.
Declaration of conformity declaration of conformity came. The machinery, product, assembly or subassembly covered by this declaration of conformity must not be put into service until. Conformity assessment procedure, notified bodies, technical standards, harmonised standards, risk assessment, ce marking. Name, address biopanda reagents ltd production address unit 14 carrowreagh business park, carrowreagh road, belfast bt16 1qq united kingdom. Higgins road suite 500 chicago, il 60631 773628 declares the referenced products are in conformance with european directives. By signing the declaration of conformity, the manufacturer or importer an importer is legally seen as the. However, the format and content of the declaration of conformity should follow a model structure to be easier to understand, especially if its in another language or alphabet. Declaration of conformity according to directive 9879ec, on in vitro diagnostic medical devices maker. Deklaracja zgodnosci ue zgodnie z dyrektywa w sprawie kompatybilnosci elektromagnetycznej.
Which information should be included in the technical documentation. This article gives some guidance on creating the document and avoiding simple mistakes. The ce marking directives impose an obligation for the manufacturer, or his authorized representative established in europe, to draw up a declaration of conformity or eu declaration of conformity as a part of the conformity assessment procedure. The object of the declaration described above is in conformity with directive 201165eu of the european parliament and of the council of 8 june 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment and is also in conformity with the below listed relevant union harmonisation legislation. The ec declaration of conformity is the written statement and the a single declaration drawn up by the manufacturer to demonstrate the fulfilment of the eu requirements relating to a product bearing the ce marking he has manufactured. The undersigned hereby declares, on behalf of the xyz corp. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which. Depending on the kind of product, the declaration can be stored electronically in the technical file, or must be provided with the product. Producing a declaration is one of the integral tasks involved in ce marking a product or machine. The declaration must be issued before the product is placed on the market in europe. The declaration of conformity is a document, wherein a manufacturer declares the compliance of a product with the requirements of the relevant directives.
The mark consists of the ce logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. And are produced under a quality scheme at least in conformity with iso 9001 or cenelec permanent documents. Eu declaration of conformity emerson to which this declaration relates, is in conformity with the provisions of the following european assumption of conformity is based on the application of the harmonized standards and, when applicable or required, a european community notified body certification, as shown in the attached schedule. Declarations of conformity abbott diabetes care division. The declaration of incorporation is used where the vendor cannot sign a declaration of conformity because and only because the product is incomplete and is designed to. Declaration of conformity although whether a copy has to be actually supplied with each product depends on the particular directives under which the ce mark has been applied. Annex language english bulgarian croatian czech danish dutch estonian finnish french german greek hungarian. Eu declaration of conformity, programmable controller simatic s71500 general germanenglish 106 s71500 general a3 02. Ec declaration of conformity of simatic hmi comfort panels germanenglish 163 hmi comfort panels a3 04. Siplus simocode pro v gg2 eudeclaration of conformity a5e32336814a004. Declaration of conformity, eceudeclaration of conformity. This declaration of conformity is issued under the sole responsibility of the manufacturer. Declaration of conformity ce deklaracja zgodnosci ce eu declaration of conformity according to the emc directive 201430eu and the low voltage directive 201435eu product name. Technical documentation and eu declaration of conformity.
Ce marking was first affixed to this product in 2011. The object of the declaration described above is in conformity with the relevant union harmonization legislation. Example of a declaration of conformity ce marking assistant. Ce marking on this model first affixed year18 2008. The word declaration of conformity is written 38 times on the eu mdr 2017745. Mysignals to which this declaration relates is in conformity with the essential requirements and other relevant requirements of the. Ultitec 2000 is in conformity with the provisions of council directive 89686eec and with the requirements for ppe of category iii. What is the euec declaration of conformity for ce marking ce mark. What is the euec declaration of conformity for ce marking. In conformance to radio equipment directive red 201453eu, abbott diabetes care makes available these declarations of conformity 1.
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