Declaration of conformity

The modules are attributed in function of the different levels of risk inherent to the products. After having applied the modules applicable to a given product, the manufacturer issues a declaration of conformity and affixes the CE-marking. 

Before a device can be legally placed on the market in Europe, it must go through an appropriate conformity assessment process to establish that it meets all the essential requirements of the applicable directive. This enables the manufacturer to make a formal declaration of conformity and apply the CE mark of conformity to the device. The manufacturer, or an authorised representative (EC Rep), who takes on the responsibilities imposed by the directives on behalf of the manufacturer, must be established in the EU. 

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. 

An abbreviated 510(k) is based on making a declaration of conformity to a recognised standard, special control, or specific FDA guidance. Again, the manufacturer must provide test data in support of this assertion. 

Device Modifications Special Controls and Declarations of Conformity... 

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 ... 

In this proposal, a manufacturer could also have the option of using a third party to assess conformance with the recognized standard. The third party could perform an assessment of conformance with the standard and provide the manufacturer with a statement to this effect, and the S10(k) application could then include the statement as well as summary on declaration of conformity. The abbreviated 510(k) submissions may compete with routine 510(k)s, and it is anticipated that their review and processing will be more efficient and timely than those of routine (traditional) submissions, which tend to be intensively data driven (Fig. 2). 

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.)... 

The EC Declaration of Conformity procedure (full quality assurance Annex IV), or... 

Annex VI) or the EC Declaration of Conformity (production quality assurance Annex VII). 

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. 

The manufacturer or his EU-resident authorized representative ensures and declares that the products fulfil the requirements given in the directive. They affix the CE mark on each product and provide a written declaration of conformity. 

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. 

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. 

A declaration of conformity is drawn up by the manufacturer or authorized representative and used to declare that the product has undergone all the necessary assessments and that the product satisfies the essential requirements of the applicable directives. This self-declaration lists the standards and directives applied, the responsible person and other necessary information as required by the directives. 

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. 

A technical file, declaration of conformity and CE marking is required under all three procedures. 

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. 

Notice This Declaration of Conformity is supported by the attached safety/EMC approval certifications, numbers S9512345 and V9554321 issued by TUV Rhein- ... 

---