The new approach - Directive

As a general rule all products covered by the New Approach directives must bear the CE-marking which symbolises conformity of the products to the requirements of the directive including the relevant certification procedures. The main principles which are basic to the application of the CE-marking can be summarised as follows ... 

Some specific needs refer to fields of particular importance, e.g. food quality including all relevant issues consumer goods governed by the New Approach Directives and relevant harmonised European standards the protection of the enviromnent and the quality of life as well as the economic concerns of the consumers dangerous substances and preparations and their impact on human beings, animals and the environment forensic science. 

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 concept of harmonized standards plays a important role in the framework of the New Approach Directives, in which it has a specific significance. ... 

Conformity with national standards that have transposed harmonized standards, whose references have been published by the Commission in the Official Journal of the European Communities, confers a presumption of conformity with the essential requirements of the New Approach Directives. ... 

Whilst CE marking enables free movement on the single market it also permits the withdrawal by the enforcement authorities of member states, of non-conforming products. Where this occurs, withdrawal of products must be formally notified to the European Commission via the RAPEX notification system, the EU rapid alert system for dangerous consumer products covering both foodstuffs and industrial products. It is also applicable to consumer products covered by the New Approach Directives. 

European directives are an important instrument of the New Approach in the field of technical harmonisation and standardisation. They are intended to remove the technical barriers by harmonising product regulations and conformity evaluations. No specifications but only essential requirements restricted to the protection of health and safety of users and the protection of environment, are laid down in the New Approach directives. Up to 2000 some 20 directives have come into force. The directives cover products where safety aspects are relevant such as lifts, pressure equipment, explosion-proof materials, toys and personal safety equipment. 

With the New Approach the number of directives needed to achieve the internal market target significantly decreased. In addition the European Council and the European Parliament were no longer required to deal with detailed technical requirements. Instead they were called upon only to define essential requirements needed to protect the public interest. The main elements of the New Approach can be summarised as follows ... 

In adopting that New Approach, the European Council was aware that this decision had to be accompanied by a policy on assessment of conformity. The Global Approach to conformity assessment provides for procedures to prove compliance of a product with the essential requirements in New Approach directives. 

In the framework of the new approach third parties have a particular responsibility. Their task has become more difficult especially in cases where products are manufactured directly to the essential requirements. In that case competent interpretation and judgement needs to be applied in order to evaluate whether the required safety level is achieved or not. Not only safeguard clauses and their economic consequences should be avoided but also possible distortion of the market. An exchange of experience between bodies which are notified for a given directive is therefore normally organised with a view to ensuring its coherent application and to avoid such negative consequences. 

Under the New Approach Member States shall not prohibit, restrict or impede the placing on the market or putting into service of products which comply with the directives and bear the CE-marking. Member States have also the obligation to take all appropriate measures to ensure that the products placed on the market do not endanger the health and safety of persons. 

The principles referred to so far are common to all New Approach directives. The individual directives obviously need to be specific on topics such as the scope, the essential requirements, the classification of the products and on the use of modules for conformity assessment. The pressure equipment directive includes some additional sector specific dispositions which relate to recognised third party organisations , the European approval for materials , a committee for pressure equipment and the user inspectorates . 

Further government regulation that totally changed how natural gas was distributed resolved this difficulty. Historically, pipeline companies were required to act as purchasers and resellers of gas. The new approach ol the 1980s limited pipelines to selling transmission seiwices. Customers of the pipelines purchase the gas directly from producers. By exiting from gas purchasing, the pipelines could similarly hack out of unattractive contracts. 

Recently, this problem has been approached by reverting to reading the color of the bilirubin directly. This used to be called an "Icterus Index", in which the color of the serum was compared to a dilute dichromate solution (39). However, the new approach has been to use two wavelengths. This can be used in either of two different procedures. In one procedure the reading is made at the peak for bilirubin which is at 453 nm and at an isosbestic point for hemoglobin (40). The effect on the reading due to hemoglobin is subtracted from the bilirubin value. Commercial instruments based on this principle have not been successful. 

New Approach Directives, as yet, cover up to 25 products or groups of products specifying the essential requirements with regard to health, safety and enviromnental issues. The concept of the New Approach in association with Technical Notification promotes aims related to the establishment of the single european market. 

The EEA law on the marketing of medical devices is governed by three principal Directives each of which adopt the Community s scheme for product regulation known as the new approach. The new approach applies to many product sectors, such as machinery, personal protective equipment, low voltage equipment and electromagnetic compatibility (EMC) requirements but not to pharmaceuticals or cosmetics. There are three device Directives. 

The essential requirements contained in Aimex I of each new approach Directive specify the aspects of safety and performance that must be satisfied at the time at which a relevant product is placed on the market. Essential requirements are stated as principles or as generalised aspects and exclude detailed technical requirements. The scheme of the Community s new approach is that detailed technical aspects are not required as legal obligations but, if they are generally accepted, may be applied voluntarily by manufacturers through being included in official standards. The essential requirements are intended to be comprehensive and all must be satisfied save for those requirements that do not apply to a particular product as a matter of common sense. 

The concepts of placing on the market and putting into service are standard in Community new approach Directives. For the purposes of the MDD, they are defined as follows ... 

The European Commission has issued guidance on these concepts in the context of all new approach Directives. In essence, a device is placed on the market when it is first put into the stream of distribution or commerce by its manufacturer. A device which is fully refurbished is treated as if it were a new device and must be subject afresh to the requirements of the Directive. Difficulties arise over the definition of what constitutes refurbishment (simple servicing is clearly not included) and aspects, such as upgrading. 

Guide to the Implementation of Directives Based on the New Approach and the Global Approach, European Commission, 2000. 

The new approach will be described using derivative cyclic voltammetry (DCV) but is readily adaptable to any of the direct kinetic techniques. In DCV, the observable is the derivative peak ratio, / j, and the variable is v. A response curve is illustrated in Fig. 18 (Ahlberg and Parker, 1981b). For an... 

A new approach, directly determining the coexistence conditions, has been proposed by us [74] and independently by Bruder and Brenn [75], providing an... 

The studies of growth by the sandwich method have provided a better understanding of the sublimation growth peculiarities and they have formed the basis of the new approach to the bulk crystal growth of silicon carbide. The first successful results in this direction were reported by Tairov and Tsvetkov [7,8]. Currently, similar studies are being performed by a number of research groups and rather impressive progress has been achieved thus far see Datareview 8.1. 

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