Conformity assessment and Notified bodies
1. Conformity assessment of products
Free movement of goods is a cornerstone of the single market. The mechanisms in place to achieve this aim are based on prevention of new barriers to trade, mutual recognition and technical harmonisation. The placing on the market and putting into service of a product can only take place when it complies with the provisions of all the technical harmonisation legislation that applies to it, and when conformity assessment has been carried out in accordance with that legislation. The manufacturer has an obligation to ensure that a product intended to be placed on the EU market is designed and manufactured, and its conformity assessed, to the essential requirements in accordance with the provisions of the applicable legislation. Conformity assessment includes activities such as testing, inspection and certification, to determine that a product fulfills the relevant requirements of the applicable technical harmonisation legislation.
Conformity assessment must not be confused with market surveillance, which consists of controls after the product has been placed on the market. However both techniques are complementary and equally necessary to ensure the smooth functioning of the internal market.
The assessment of the conformity of a product is carried out before that product is placed on the market and consists in demonstrating that it fulfils all the legislative requirements that apply to it. Conformity assessment is performed following technical procedures which are specified in the sectoral legislation.
Manufacturers may choose between different conformity assessment procedures provided for in the applicable directive(s). The assessment of the conformity of a product may be carried out either by the manufacturer himself or by a conformity assessment body (manufacturer's in-house or 'external' – see: Notified bodies), depending on the provisions of the modules selected by the relevant sectoral legislative instrument.
1.1 Conformity assessment procedures and Declaration of conformity
Conformity assessment procedures demonstrate that a product, before it is placed on the market, conforms to the essential requirements of the legislative requirements that apply to it.
The essential objective of a conformity assessment procedure is to demonstrate to public authorities that a product being placed on the market conforms to the requirements as expressed in the provisions of the relevant legislation, in particular with regard to the health and safety of users and consumers. The purpose of conformity assessment procedures is thus to ensure confidence on all sides as regards the conformity of products to the relevant essential requirements. As a general rule a product should be covered by conformity assessment during both the design and production phase.
1.1.1 The modules
The sectoral directives specify the combination of modules, i.e. conformity assessment procedures, that cover both the design and production phases and are available to the manufacturer to demonstrate conformity.
Conformity assessment is subdivided into modules, and conformity assessment procedures are composed of one or more conformity assessment modules. The modules relate either to the design phase of products, the production phase, or both. A conformity assessment procedure should cover both the design and production phases, while a module may cover either one of these phases (when a conformity assessment procedure is composed of two modules) or both (when a conformity assessment procedure comprises just one module).
Each directive describes the range and contents of possible conformity assessment procedures, which are considered to give the necessary level of protection. The directives also set out the criteria governing the conditions under which the manufacturer can make a choice, if more than one option is provided for.
1.1.2 EC declaration of conformity
The manufacturer or the authorised representative established within the EU must draw up an EC declaration of conformity (DoC) as part of the conformity assessment procedure provided for in the applicable legislation. The EC declaration of conformity should contain all relevant information to identify the legislation according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other normative documents.
2. Notified bodies
2.1 Principles of notification
Notified bodies carry out the tasks pertaining to the conformity assessment procedures referred to in the applicable technical harmonisation legislation when a third party is required. It is the responsibility of the Member States to notify those ('external') conformity assessment bodies within their jurisdiction that are technically competent to assess the compliance of products with the requirements of the directives(s) that apply to them. They may choose the bodies they notify from the bodies under their jurisdiction which comply with the requirements of the directives and the principles laid down in Decision EC/2008/768 .
The assessment of the body seeking notification determines if it is technically competent and capable of carrying out the conformity assessment procedures in question, and if it can demonstrate the necessary level of independence, impartiality and integrity. Further, the competence of the notified body should be subject to surveillance, which is carried out at regular intervals and follows the practice established by the accreditation organisations.
The EN ISO/IEC 17000 series of standards and accreditation are important instruments to help in establishing conformity with the requirements of the applicable legislation.
In-house bodies do not need to be notified but they have still to demonstrate the same technical competence as external bodies. Member States must also ensure that both in-house and external bodies maintain their technical competence.
2.2 Notified bodies and conformity assessment
The primary task of a notified body is to provide services for conformity assessment under the conditions set out in the directives. This is a service to the manufacturers in an area of public interest. Notified bodies are free to offer their conformity assessment services, within their scope of notification, to any economic operator established either inside or outside the EU. They may also carry out these activities on the territory of other Member States or of third countries.
Manufacturers are free to choose any notified body that has been designated to carry out the conformity assessment procedure in question according to the applicable directive.
2.3 Notification procedure and withdrawal of notification
Notification is an act to inform the Commission and the other Member States that a body, which fulfils the requirements, has been designated to carry out conformity assessment according to technical harmonisation legislation. The Commission publishes lists of notified bodies for information purposes on its web site for Notified Bodies, NANDO.
Withdrawal of notification takes place when the notified body ceases to fulfil the requirements or its obligations. Withdrawal is the responsibility of the notifying Member State. It can also be the end result of an infringement procedure.
2.4 General responsibilities of notified bodies
Notified bodies must operate in a competent, non-discriminatory, transparent, neutral, independent and impartial manner. They must employ the necessary personnel, with sufficient and relevant knowledge and experience to carry out conformity assessment in accordance with the directive(s) in question.
Notified bodies must make adequate arrangements to ensure confidentiality of the information obtained in the course of conformity assessment, and be adequately insured to cover their professional activities, unless liability is assured under the national legislation of the notifying Member State. They must also provide relevant information to their notifying authority, the market surveillance authorities and other notified bodies.
2.5 Notified bodies and subcontracting
A notified body can have part of its work carried out by another body on the basis of established and regularly monitored competence. The body subcontracted by the notified body must be technically competent, and display independence and objectivity according to the same criteria and under the same conditions as the notified body. However, notification is not necessary. The Member State that has notified the body, which subcontracts part of its work, must be capable of ensuring effective monitoring of the competence of the body subcontracted by the notified body.
A further condition for subcontracting is that the conformity assessment procedure can be subdivided into technical operations and assessment operations, and that the methodology used to carry out the technical operations is sufficiently precise. The body subcontracted by the notified body must, nevertheless, carry out substantial and coherent parts of these technical operations.
Subcontracting must be based on a contract, which makes it possible to ensure the transparency of and have confidence in the notified body’s operations. A subcontracting notified body remains responsible for all the activities covered by the notification. Subcontracting does not entail the delegation of powers or responsibilities. Certificates are always issued in the name and under the responsibility of the notified body. The conditions for subcontracting apply to any subcontractor whether or not established within the Community.
2.6 Coordination and cooperation of notified bodies
Notified bodies participate in coordination activities. A coherent application of the conformity assessment procedures requires close cooperation between the notified bodies, the Member States and the European Commission. The Commission supports the Member States in their efforts to establish coherence between the notifying authorities regarding, in particular, the assessment of the competence of the bodies to be notified, the application of notification procedures and the surveillance of notified bodies. The Commission, in coordination with Member States, also ensures that cooperation is organised between the notified bodies. They should also take part directly or be represented in European standardisation, or otherwise ensure that they know the situation of relevant standards.
2.7 The NANDO web site
The Member States, EFTA countries (EEA members) and other countries with which the EU has concluded Mutual Recognition Agreements (MRAs) and Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) have designated Notified Bodies, established per directive. Lists of Notified Bodies can be searched on the NANDO web site (New Approach Notified and Designated Organisations). The lists include the identification number of each notified body as well as the tasks for which it has been notified, and are subject to regular update.
The lists of notified bodies are given for information only and are valid at the date indicated. Information is made available as provided by the designating authorities of the Member States. Any comments concerning the information contained in the lists should be addressed directly to the relevant competent authorities in the Member States which are responsible for the designation of the bodies.