Technical documentation requirement - CE
Active implantable medical devicesPrior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.
The manufacturer or his authorised representative established in the European Community is required to keep copies of the technical documentation for a period of at least 15 years, after the last product has been placed on the market.
Appliances burning gaseous fuels
Directive 2009/142/EC on appliances burning gaseous fuels requires that the application for type-examination must include, among other things, the design documentation as described in Annex IV.The design documentation must contain the following information, in so far as is required by the Notified Body for assessment:
[*]a general description of the appliance,
[*]conceptual designs and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
[*]descriptions and explanations necessary for the understanding of the above, including the operation of the appliances,
[*]a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards referred to in Article 5 have not been applied,
[*]test reports, — manuals for installation and use,
[*]where appropriate, the design documentation must contain the following elements:
[*]attestations relating to the equipment incorporated in the appliance,
[*]attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance,
[*]any other document making it possible for the Notified Body to improve its assessment.
The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Cableway installations designed to carry persons
Requirements regarding technical documentation for the different conformity assessment procedures are set up under Annex V to the Directive.
Construction products
Please consult http://ec.europa.eu/growth/sectors/construction/index_en.htm.
Eco-design of energy related products
Upon successful assessment, the Ecodesign Directive 2009/125/EC requires technical documentation as laid out in Annex V. The technical documents must enable assessment of the conformity of the appliance with the requirements of the Directive. The technical file should comprise:
[*]A general description of the product and of its intended use;
[*]The results of relevant environmental assessment studies carried out by the manufacturer or alternatively references to environmental assessment literature or case studies, which have been used by the manufacturer in evaluating, documenting and determining product design solutions;
[*]The ecological profile, where required by the implementing measure;
[*]Documents describing the results of measurements on the eco-design requirements carried out;
[*]The manufacturer must establish specifications indicating, in particular, which standards were or were not applied and ultimately, what means have been used to ensure compliance;
[*]A copy of the information concerning the environmental design aspects of the product provided in accordance with the requirements (specified in Annex I, Part 2);
[*]A copy of the EC declaration of conformity.
The manufacturer or his authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.
Electromagnetic compatibility
Annex II to the EMC Directive requires the manufacturer to establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical documentation should comprise:
[*]A general description of the apparatus;
[*]Evidence of compliance with the harmonised standards, if any, applied in full or in part;
[*]Where the manufacturer has not applied harmonised standards, or has applied them only in part, a description and explanation of the steps taken to meet the essential requirements of the Directive, including a description of the electromagnetic compatibility assessment set out in Annex II, point 1, results of design calculations made, examinations carried out, test reports, etc;
[*]A statement from the notified body, when the procedure referred to in Annex III has been followed.
The manufacturer or his authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed on the market.
Equipment and protective systems intended for use potentially explosive atmospheres
After completion of the conformity assessment, the procedure has to be documented as set out in ATEX Directive 94/9/EC, Annex III, Nr. 3, for the EC-type examination. The technical documents must enable the assessment of the appliance’s conformity with the requirements of the Directive. The technical file should comprise:
[*]a general type-description,
[*]design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.,
[*]descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product,
[*]a list of the harmonised standards, applied in full or in part,
[*]descriptions of the solutions adopted to meet the essential requirements of the Directive where harmonised standards have not been applied,
[*]results of design calculations made, examinations carried out, etc.,
[*]test reports.
The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.
Explosives for civil usesAfter completion of the assessment, the assessment procedure must be documented as set out inDirective 93/15/EEC, Annex II, Nr. 3.The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. They must, as far as is relevant for such assessment, cover the design, manufacture and operation of the appliance and contain as far as is relevant for assessment:
[*]a general type-description,
[*]conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
[*]descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the product,
[*]a list of the standards referred to in Article 4, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
[*]results of design calculations made, examinations carried out, etc.,
[*]test reports.
The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.
Hot-water boilersUpon successful assessment of the product, Directive 2009/142/EC demands technical documentation, as laid out in Annex III, Nr. 3. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The assessment must cover the design, manufacture and operation of the appliance, and contain:
[*]a general type-description,
[*]conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
[*]descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the product,
[*]a list of the standards referred to in Article 5 (2), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards, as referred to in Article 5, have not been applied,
[*]results of design calculations made, examinations carried out, etc.,
[*]test reports.
The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.
In vitro diagnostic medical devicesPrior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.
LiftsUpon successful assessment, Directive 95/16/EC on lifts requires technical documentation (e.g. as laid out in Annex 5) according to the respective conformity assessment procedure. The technical documents must enable assessment of the conformity of the appliance with the requirements of the Directive. The assessment must cover the design, the manufacturing and the operation of the installation and contain:
[*]a general description of the safety component, including its area of use (in particular possible limits on speed, load and power) and conditions (in particular explosive environments and exposure to the elements),
[*]a lift installation technical dossier,
[*]design and manufacturing drawings or diagrams,
[*]essential requirement(s) taken into consideration and the means adopted to satisfy it (them) (e.g. a harmonised standard),
[*]results of any tests or calculations performed or subcontracted by the manufacturer,
[*]a copy of the assembly instructions for the safety components,
[*]steps taken at the manufacturing stage to ensure that series-produced safety components conform to the safety component examined.
The manufacturer of the safety component for lifts or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last the safety component for lifts is placed on the market.
Low voltageAfter completion of the assessment, the assessment procedure must be documented as set out in Directive 2006/95/EC, Annex IV, Nr. 3.The technical documents must enable the assessment of conformity of the appliance with the requirements of the Directive. It must, as far as it is relevant for such an assessment, cover the design, manufacture and operation of the electrical equipment. The technical file should comprise:
[*]a general description of the electrical equipment,
[*]conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
[*]descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment,
[*]a list of the standards applied in full or in part, and descriptions of the solutions adopted to satisfy the safety aspects of this Directive where standards have not been applied,
[*]results of design calculations made, examinations carried out, etc.,
[*]test reports.
The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.
Machinery
Upon successful assessment, Directive 2006/42/EC on Machinery requires a technical documentation as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.The technical file should comprise:
[*]a detailed documentation on the construction of the machinery including drawings of the machinery and its parts,
[*]test results,
[*]description of protective measures
[*]other elements as described in Annex VII, A(a).Also, the file must contain a copy of the EC declaration of conformity.
The manufacturer must also provide documents for series production and internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive (Annex VII, A (b)).The manufacturer must carry out the necessary tests on components, fittings or the completed machinery to determine whether it can be assembled and put into service safely. The relevant reports and results shall be included in the technical file.The manufacturer or his authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.
Measuring InstrumentsAccording to Directive 2004/22/EC, the technical documentation for measuring instruments must depict the design, manufacture and operation instructions of the instrument. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. In detail, Article 10, Nr. 2 lists the documentation of:
[*]the definition of the metrological characteristics,
[*]the reproducibility of the metrological performances of produced instruments when properly adjusted using appropriate intended means, and
[*]the integrity of the instrument.
More details are listed in Article 10 depending on the type of instrument. Please consult your Directive for an extensive list.The manufacturer, or his authorised representative, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.
Medical devicesPrior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.The manufacturer or the authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of at least 5 years, in the case of implantable devices at least 15 years, after the last product has been placed on the market.
Noise emission in the environmentUpon successful assessment, Directive 2000/14/EC on Noise emission in the environment requires a technical documentation as laid out in Annexes V – VIII (see art 14.3). The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical file should comprise:
[*]The name and address of the manufacturer or his authorised representative established in the Community
[*]A description of the equipment
[*]The trade name
[*]The type, series and numbers
[*]The technical data relevant for the identification of the equipment and the assessment of its noise emission, including, if appropriate, schematic drawings and any description and explanation necessary for their understanding
[*]The reference to the Directive
[*]The technical report of noise measurements carried out in accordance with the provisions of the Directive
[*]The technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level.
The file must also contain a copy of the EC declaration of conformity.The manufacturer or their authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Non-automatic weighing instrumentsAnnex III to the Directive non-automatic weighing instruments requires the manufacturer to establish a technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The documentation must cover:
[*]a general description of the type,
[*]conceptual designs and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.,
[*]descriptions and explanations necessary for the understanding of the above, including the operation of the instrument,
[*]a list of the harmonised standards referred to in Article 6(1), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied,
[*]results of design calculations made and of examinations, etc.,
[*]test reports,
[*]the EC type-approval certificates and the results of relevant tests on instruments containing parts identical to those in the design.
The manufacturer, or their authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Personal protective equipmentThe PPE Directive 89/686/EEC requires a technical documentation as laid out in Article 8 (1). It must enable the assessment of the conformity of the PPE with the requirements of the Directive. It must comprise all relevant data on the means used by the manufacturer to ensure that a PPE complies with the basic requirements relating to it. In case of category II and III PPE is shall comprise in particular:
[*]the manufacturer's technical file consisting of:
[*]overall and detailed plans of the PPE accompanied, where appropriate, by calculation notes and the results of prototype tests in so far as necessary for the verification of compliance with the basic requirements;
[*]an exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications referred to in Articles 3 and 5, taken into account in the design of the model;
[*]a description of the control and test facilities to be used in the manufacturer's plant to check compliance of production PPE with the harmonized standards or other technical specifications and to maintain quality level;
[*]a copy of the information notice referred to in Annex II, 1.4.
The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Pressure equipmentDirective 97/23/EC on Pressure Equipment requires the manufacturer to establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The documentation must cover e.g.:
[*]a general description of the pressure equipment
[*]conceptual design and manufacturing drawings
[*]descriptions and explanations necessary for an understanding of the
[*]drawings and the operation of the pressure equipment
[*]a list of the harmonised standards applied and a description of the solutions adopted to meet the essential safety requirements where harmonised standards have not been applied
[*]result of design calculations made, examinations carried out etc.
[*]test reports
The manufacturer or their authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of 10 years after the last product has been manufactured.
Pyrotechnics
Upon successful assessment, Directive 2007/23/EC on Pyrotechnic Articles outlines different variations for a technical documentation depending on the assessment procedure chosen, as laid out in Annex II The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical file should basically comprise:
[*]a general description of the type,
[*]conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits,
[*]the descriptions and explanations necessary for the understanding of the conceptual design and manufacturing drawings, the schemes of components, sub-assemblies and circuits and the operation of the pyrotechnic article,
[*]a list of the harmonised standards referred to in Article 8 of the Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where the harmonised standards referred to in Article 8 of this Directive have not been applied,
[*]results of design calculations made and examinations carried out,
[*]test reports.
Also, the file must contain a copy of the EC declaration of conformity.The manufacturer is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Radio and telecommunications terminal equipmentPoint 4 of Annex II describes the technical documentation. The technical documents must enable the assessment of the conformity of the product with the requirements of the Directive. The documentation must cover:
[*]a general description of the product;
[*]a conceptual design and manufacturing drawings;
[*]schemes of components, sub-assemblies, circuits, etc.;
[*]descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product;
[*]a list of the standards referred to in Article 5, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards referred to in Article 5 have not been applied or do not exist;
[*]results of design calculations made, examinations carried out, etc.;
[*]test reports.
The manufacturer or their authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.What about information for the user? See article 6.3 of the Directive, and its language regime which depends on national regimes. Any potential restrictions or requirements for authorisation of use of the radio equipment in certain Member States shall be marked in order to alert the user.
Recreational craftAnnexes V, VII, VIII, IX, XI and XVI to the Directive 94/25/EC on Recreational Crafts require the manufacturer to establish a technical documentation. The technical documents must enable the assessment of the conformity of the product with the requirements of the Directive. The documentation must cover:
[*]a general description of the type,
[*]conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
[*]descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,
[*]a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to fulfil the essential requirements when the standards referred to in Article 5 have not been applied,
[*]results of design calculations made, examinations carried out, etc.,
[*]test reports, or calculations namely on stability according to point 3.2 of the Essential Requirements and on buoyancy according to point 3.3 of the Essential Requirements.
[*]test reports, or calculations namely on stability according to section 3.2 of the Essential Requirements and on buoyancy according to section 3.3 there of (Annex I.A),
[*]exhaust emissions test reports demonstrating compliance with section 2 of the Essential Requirements (Annex I.B)
The manufacturer or their authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Restriction of Hazardous Substances in Electrical and Electronic EquipmentPlease consult http://ec.europa.eu/environment/waste/rohs_eee/legis_en.htm.
Safety of toys
Upon successful assessment, Directive (2009/48/EC) requires a technical documentation as laid out in Article 21. The technical documents must enable the conformity of the toy with the requirements of the Directive to be assessed. The following documentation is required:
[*]a description of the means (such as the use of a test report or technical file) whereby the manufacturer ensures conformity of production with the standards referred to in Article 13
[*]where appropriate: an EC type-certificate drawn up by an notified body; copies of the documents the manufacturer has submitted to the notified body; a description of the means whereby the manufacturer ensures conformity with the approved model,
[*]the addresses of the locations used for manufacture and storage of the product, detailed information concerning the design and manufacture of the product.
The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
Simple pressure vessels
Annex II to Directive 2009/105/EC on simple pressure vessels requires the manufacturer to prepare design and manufacturing schedules (technical documentation) enabling the assessment of the conformity of the equipment with the requirements of the Directive. The documentation must cover e.g.:
[*]a detailed manufacturing drawing of the vessel type;
[*]the instructions;
[*]a document describing:
[*]the materials selected,
[*]the welding processes selected,
[*]the checks selected.
The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.
http://ec.europa.eu/growth/single-market/ce-marking/manufacturers/documentation/index_en.htm
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