§5.2.3 Competence of notified bodies

The primary task of a notified body is to provide conformity assessment services on the conditions set out in the applicable Union harmonisation legislation. This is a service to the manufacturers in an area of public interest. Notified bodies are designated to assess conformity with the essential requirements, and to ensure consistent technical application of these requirements according to the relevant procedures in the applicable Union harmonisation legislation. The notified bodies must have appropriate facilities and technical staff that enable them to carry out technical and administrative tasks related to conformity assessment. They must also apply appropriate procedures of quality control in relation to such services provided. 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 Union harmonisation legislation. Some sectoral legislation provides for the application of a conformity assessment module that provides for the mandatory involvement of a notified body (e.g. EU-type examination) in cases where harmonised standards do not exist or are not applied by the manufacturer. Consequently, in order to ensure a correct implementation of the internal market rules, Notified Bodies are required to be able to demonstrate that they have the competences to perform the required conformity assessment and to issue the required attestation to certify that the regulatory requirements have been fulfilled, also in the (complete) absence of harmonised standards. A notified body wishing to offer services according to several conformity assessment procedures must fulfil the relevant requirements for the respective tasks, and this has to be assessed according to the requirements for each different procedure in question. However, since the scope of much technical harmonisation legislation can be relatively wide and heterogeneous, a notified body does not need to be qualified to cover all products falling within the scope of that legislation, but may be notified for a defined range of products only. Notified bodies must have appropriate structures and procedures to ensure that the conduct of conformity assessment and the issuing of certificates are subject to a review process. Relevant procedures must, in particular, cover obligations and responsibilities in relation to suspension and withdrawal of certificates, requests addressed to the manufacturer to take corrective measures, and reporting to the competent authority. Apart from carrying out certain responsibilities in the field of public interest, notified bodies must regard themselves as rendering services to industry. Thus, they should provide relevant information to the manufacturer and the authorised representative regarding the legislation in question, apply the conformity assessment procedure without unnecessary burdens for the economic operators, and refrain from proposing additional certification or marking that has no added value for the conformity assessment of the product. The latter activities must be clearly separated from the activities of the body as a notified body. Notified bodies cannot use their notified body number to carry out these activities. To avoid unnecessary burdens for economic operators and help in ensuring the protection of confidential data or intellectual property rights, the technical documentation provided to notified bodies has to be limited to that which is required solely for the purpose of assessing conformity to the legislation. The manufacturer can provide test reports or other elements of its technical documentation. The notified body can take these reports into account if it assumes full responsibility for the results. The notified body may accept the manufacturer’s test results for the conformity assessment provided that it justifies the reason for taking account of these tests. However, accepting the results of the manufacturer’s tests is not as such sufficient to fulfil its tasks as notified bodies and additional tests will have to be performed under the applicable module by the Notified Body.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07