Declaration of conformity for

The manufacturer or his EU-resident authorized representative stores a copy of the declaration of conformity for at least 10 years after the end of manufacturing this product. 

Note. In some cases a type C product standard may not exist for a particular machine or product. In this case type A and B standards are used, along with the relevant EU national standards (if available), to assess the machine for safety or EMC, and these standards are then listed on the declaration of conformity for the CE marking. Use of a EU-notified/competent body may be required for products where no type C standard exists. 

After the conclusion of the conformity assessment procedure and of the tests perhaps required, the manufacturer issues an EC-declaration of conformity for his product. He affixes the explosion protection marking (Ex marking) to the product and if the product fulfills the requirements of other applicable European directives he affixes a CE marking to the product as well. 

Different conformity assessment options are available, depending on the type of device and the level of associated risk. For lotv-risk devices, the manufacturer can make a declaration of conformity based solely on self-assessment, without the need for the involvement of a Notified Body. For all other devices Notified Bodies are required to perform one or more of the tasks outlined in Table 10.2. HIV and hepatitis tests and blood grouping tests represent the highest risk devices, as they are critical to ensuring the safety of blood and blood products. For example, a defective HIV test device could result in widespread infection in an unsuspecting population, whereas the detrimental effects ofan AIMD or a Class III device failure will just be confined to the individuals treated by the device. At this end of the risk spectrum. Notified Bodies are required to verify the applied quality system, the specific device design, and the... 

For low-risk devices the manufacturer may make a declaration of conformity with the essential requirements on the basis of a self-assessment, without any input from a Notified Body. In the case of Clas s I devices that are sterile or have a measuring function. Notified Body involvement is required, to provide assurance as to the effectiveness of the sterilisation process or the meteorological traceability of values as appropriate. 

A new 510(k) paradigm provides guidance for sponsors of 510(k)s to consider and use national and international standards and a mechanism for declaration of conformity assessment criteria for these standards. It is expected that many domestic and international standards will address, in part or full, certain aspects of... 

Under this proposal, device manufacturers could choose to use horizontal standards for class II devices when an SCGD exists or when the FDA has recognized an individual special control such as relevant vertical standards (e.g., prostate-specific antigen). In addition to the required elements of a 510(k) (21 CFR 807.87), these applications could include summary information that describes how special controls have been used to address the risks associated with the device type and a declaration of conformity with any relevant recognized standard(s), as applicable. As expected, a declaration of conformity with a standard would provide a summary of a manufacturer s efforts to conform with the recognized standard and would outline any deviations specifying ... 

A manufacturer must apply an appropriate conformity assessment procedure to their device in order to ensure that it complies with the essential requirements, after which they must certify this fact by completing a declaration of conformity. There is usually a choice of conformity assessment procedures open to a manufacturer, depending on a risk-based classification of the class into which the device falls. The two main approaches to conformity assessment are based either on an approved total quality management system audited to ISO 9000 series standard, as customised for medical devices with EN 46 000 series standard, or individual product assessment. 

For products in Class I, the manufacturer must have specified technical documentation on the design of the product showing that it conforms to the essential requirements manufacturing aspects are not covered and a notified body is not involved imless there is a measuring function and/or the product is sterilised. (Annex VII EC declaration of conformity.)... 

All devices other than those covered by Annex II are subject to the EC Declaration of Conformity procedure (Annex III), which does not involve the intervention of a notified body, but which includes supplementary requirements for devices for self-testing, which does involve a notified body (Annex III). 

The guarantee of conformity to the essential requirements of the MDD is provided by the interaction between the manufacturer and a third party, the notified body. The notified bodies are organizations that are recognized by the member states to conduct device evaluations and inspections of the quality systems of the various manufacturers. The manufacturers are held responsible for the quality, safety, and effectiveness of their medical devices. This is enforced through the manufacturer s written declaration of conformity and commitment to keep all technical information available for inspection by the notified bodies and national authorities. 

Electro-magnetic compatibility Declaration of Conformity certificates (self-certification) for equipment containing European Union (EU) CE-marked equipment (e.g., panels)... 

Declaration of conformity In accordance with BS 12413 (and oSa logo for members). 

What s needed in conjunction with affixing the CE Marking—With the product supplier s CE marking mandatory for most products, the supplier s declaration of conformity and technical file must also be readily available on demand by enforcement authorities. 

For most products and machines, the self-declaration process (module A) is possible. In practice the manufacturer performs the complete product assessment according to EU standards, issues the declaration, and affixes the CE marking to the product. A technical file or documentation must also be available on demand for national enforcement authorities. Keep in mind that this is an internal self-assessment process, a do-it-yourself approach, that results in issuance of the manufacturer s declaration of conformity and the CE marking (Figure 2-6). The buyer may demand proof of safety/EMC compliance in the form of a mark, certificate, or test report from a European notified or competent body. 

Self-declaration. This route is available for products/machines where a mandatory type exam is not required. This route allows internal control of production through product assessment and testing by the manufacturer. Under self-declaration, the manufacturer takes complete responsibility for the assessment, testing, documentation, and declaration of conformity and CE marking. 

Mandatory certification. Most products and machines do not require mandatory certification. But in such cases, as with some high-risk machinery or when harmonized standards do not exist or are not applied in full, a type examination by a notified body is required. After successful testing, a Type-Exam Certificate for machinery or Certificate of Conformity for EMC is issued by the EU Body. The manufacturer then affixes the CE marking and issues a declaration of conformity. 

The term CE mark was changed to CE Marking in the New Approach Directives. The CE marking is not a mark and therefore must not be confused with a mark, certificate, or approval issued by an accredited certification body, as listed in the Official Journal. Rather, the CE marking is a symbol of the manufacturer s declaration of conformity that implies conformity with the minimum requirements set out in the Directives. The CE symbol is not a registered mark, which is in principle under the manufacturer s own responsibility. The CE marking is a declaration for the inspectors (i.e., customs) and allows the product to be placed on the market. ... 

The EC declaration of conformity must contain the following elements reference to the harmonized standards (see directive for other elements) (93/68/EEC, No L220, p. 21). 

In the case of challenge by the authorities in charge of market surveillance, a report in the sense of Article 8(2) (which, however, is not mandatory) is considered an element of proof. In fact, in addition to the three basic conformity assessment measures [technical documentation, declaration of conformity, and CE marking]. Article 8(2) provides, in the event that conformity is challenged, for the possible submission to the market surveillance authority of a report drawn up by a notified body as evidence that the electrical equipment complies with the safety objectives. (Article 2 and Annex 1)... 

CE marking is the manufacturers self-declaration symbol indicating conformity with the essential requirements of all relevant directives. The product CE marking and declaration of conformity is mandatory for most products. A technical file describing the product, design, assessment, tests, standards applied, rationale, etc., shall also be readily available. 

Over 50% of 3,000 machines inspected in Sweden failed to comply with documentation and labeling rules. The authorities were only performing administration checks for the CE marking, declaration of conformity, and manuals this time—more to come ... 

Safety components such as light curtains, sensor mats, and two-hand controls are regulated by Machinery Directive 89/392/EEC which requires a manufacturer s declaration of conformity but no CE marking. EU type-approval marks are also highly recommended for safety components. 

CE marking and declarations of conformity should not be considered as evidence of compliance for components, products, or machines. 

Technical file. The manufacturer s technical documentation file supports the CE marking. The contents of a technical file generally include the declaration of conformity, name and address of manufacturer, product description and identification, list of standards and directives applied, design and schematic drawings, calculations, test reports, parts lists, manuals, and so on. Technical files must be readily available and may be requested by enforcement authorities for inspection purposes should a product become suspect or an incident occur. 

The requirements for European Community (EC)-type certification are declaration of conformity and technical documentation files for all categories of gloves. For categories II and III, there are additional requirements EC-type examination testing by approved laboratories, certified by approved notified bodies and manufacturing under a formal EC quality assurance system. 

ISO/lEC Guide 22 Information on Manufacturer s Declaration of Conformity Ith Standards or Other Technical Specifications. 1st ed., International Organi-zation for Standardization, Geneve, Switzerland 1982. 

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