Conformity declaration

Purchasers and consumers ask for a structured and transparent conformity assessment process in which impartiality and competency is crucial for their trust. Accreditation can provide impartial and independent evidence of the ability of conformity assessment organisations e.g. certification bodies to provide satisfactory certification. Conformity declarations, which are issued under accreditation, express the confidence that organisations work in accordance with a pre-determined standard so that the infrastructure is demonstrably present for supplying high-quality services and products. 

Regulation 11 contains requirements for record-keeping. Any EC conformity declaration received must be kept for as long as the equipment is operated. The reports of thorough examination must be kept as follows ... 

Declare the conformity or non conformity of the particular flaw detector under test, in accordance with the criteria of CEN standards. 

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. 

The impact of this requirement depends upon what constitutes the specified requirements. The standard does not require you to demonstrate conformance with every requirement of ISO 9001. However, if your customer has invoked ISO 9001 in the contract, this clause requires that you maintain sufficient records to demonstrate compliance. As stated elsewhere in this book, there is no definition clarifying what specified requirements are. If specified requirements are a//the requirements that you have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard. A pragmatic approach to take is to declare in your quality manual that the specified requirements are specified customer requirements . 

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). 

Once the qualification protocols are complete, a qualification report is written. The qualification report should summarize the results from each of the protocols, explain any deviations or non-conforming data, and declare that the instrument is suitable for use (or unsuitable if the acceptance criteria were not met or the non-conforming data could not be justified). 

The derivatives of In g and B of a single conformation which correspond to the y. torsional angle, have been calculated numerically using the double precision declaration as real 16. For this purpose, nine values of B and Ing around y,(Tr + Ay, y, + 2Ay. . . and y,- - Ay, y, - 2Ay. . . ) have been calculated. The grid has been defined for Ay = 10 rad The resulting nine values have been fitted to four termed Taylor series which were derived. The numerical derivatives are identical (up to 15 decimal numbers) to those obtained analytically with the C algorithm shown in Table 3. 

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). 

Authenticity Conformity of the declared and real origin of a raw material. Are materials which are declared as natural really natural and not synthetic ... 

A force field for solid state modeling of fluoropolymers predicted a suitable helical conformation but required further improvement in describing intermole-cular effects. Though victory cannot yet be declared, the derived force fields improve substantially on those previously available. Preliminary molecular dynamics simulations with the interim force field indicate that modeling of PTFE chain behavior can now be done in an all-inclusive manner instead of the piecemeal focus on isolated motions and defects required previously. Further refinement of the force field with a backbone dihedral term capable of reproducing the complex torsional profile of perfluorocarbons has provided a parameterization that promises both qualitative and quantitative modeling of fluoropolymer behavior in the near future. 

This decree is an international consensus to recognise studies carried- out in different countries. Any laboratory wanting to conform to GLP can ask for an inspection. If it passes the inspection, the laboratory is declared GLP compliant, which allows it to operate within the scope of the European community regulations. However, GLP compliance does not give a laboratory a label of quality that is valid for all future operations. 

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. 

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