5.2.2 役割及び責任

Although the notified body must be established on the territory of the notifying Member State, it may have activities or personnel outside the Member State, or even outside the Union. Certificates and other conformity assessment attestations are, however, always issued by and in the name of the notified body (246). Since the notified body always has to carry out its assessment functions within the jurisdiction of the designating Member State, it has to inform the notifying authority, which must be capable of ensuring the monitoring of the total body as it has to take the responsibility for its operations. If monitoring is not considered possible, the notifying authority should withdraw or limit the scope of the notification as deemed necessary.

Notified bodies must keep their national notifying authorities informed of their activities (for example concerning the conduct of conformity assessments, availability of resources, subcontracting, situations of conflicts of interest), either directly or via an authorised body (for example the national accreditation body). They must also be prepared to provide either at the request of their notifying authorities or of the Commission, all information concerning the proper implementation of the conditions under which they were notified.

Notified bodies have a general obligation to inform the notifying authority about all certificates refused, restricted, suspended or withdrawn due to safety related non-conformities and, on request, about certificates issued or other conformity assessment activities performed. In addition, notified bodies must provide other bodies notified under the same Union harmonisation legislation, carrying out similar conformity assessment activities covering the same products, with relevant information on issues relating to negative and, on request, positive conformity assessment results. Given the confidentiality requirements that notified bodies have to observe when fulfilling their tasks, the information to be shared with other notified bodies cannot concern confidential commercial information on the product. Relevant information to be exchanged on issues relating to negative conformity assessment results should thus primarily concern the refusal to issue a conformity assessment attestation identifying the product and manufacturer in question.

They must also provide the market surveillance authority and, according to some Union harmonisation legislation also the market surveillance authorities of other Member States, with relevant information for the purpose of market surveillance. Notified bodies as such are not responsible for providing the EU Declaration of Conformity or the technical documentation. Having said that, in line with the applicable conformity assessment procedure, they might have to keep the technical documentation as part of the technical file and provide it to the Commission or the Member States upon request (247). Further, notified bodies must provide, on request of the Commission department responsible for administering a safeguard clause, the necessary information related to the product or the conformity assessment.

Notified bodies are and must remain third parties independent of their clients and other interested parties. The legal status of bodies seeking notification, whether they are private or state-owned, is irrelevant as long as their independence, impartiality and integrity are ensured, and they are identifiable as a legal entity bearing rights and obligations.

The requirement for independence covers the whole organisation, including the board of directors, and applies also for bodies belonging to business associations or professional federations.

In order to guarantee impartiality, the notified body and its staff have to be free from any commercial, financial and other pressure that might influence their judgement. The body also has to implement procedures to ensure that its work cannot be influenced from outside. The structure of the body must safeguard its impartiality, especially if the body has activities other than those of a notified body.

Furthermore, the body must have policies and procedures that distinguish between the tasks it carries out as a notified body and any other activity in which it is engaged, and it must make this distinction clear to its customers. Accordingly, marketing material must not give any impression that assessment or other activities carried out by the body are linked with tasks described in the applicable Union harmonisation legislation.

When a conformity assessment body delivers a test report it is in its capacity as a conformity assessment body; only in its capacity as notified body can it deliver EU-type examination certificates – a certificate bearing in particular the name and identification number of the notified body. In no circumstances must the notified body issue a test report carrying its notified body number (248) in relation to tests that are not specified in the legislation, whether those tests were carried out by the body itself or by another body. Moreover, a notified body may only use its number in relation to conformity assessment activities carried out under the specific conformity assessment module that requires the intervention of a notified body, and for which it has been notified.

Accredited Notified Bodies should act as such and always mention in the certificates they issue the fact that they are accredited, where the activity is covered by the accreditation certificate.

A notified body must require the manufacturer to take appropriate corrective measure and, if necessary suspend or withdraw a certificate it has issued, if in the course of the monitoring of conformity following the issue of the certificate, it finds that the product no longer complies (249).

In their capacity of notified bodies, they must not offer or provide additional services unless they have an added value for the conformity assessment of the product. However, notified bodies may offer any type of conformity assessment services and markings where the products are intended for the markets of third countries outside the European Union, for example in the context of Mutual Recognition Agreements (250). Such activities must be clearly separated from the activities of the body as a notified body. Notified bodies must also ensure that their activities outside the scope of technical harmonisation legislation do not compromise or diminish confidence in their competence, objectivity, impartiality or operational integrity as notified bodies. Notified bodies cannot use their notified body number to carry out these activities. Notified bodies should particularly refrain from issuing certificates under their Notified Body number for the purposes of other Union harmonisation legislation than the one for which they are notified and which also require the intervention of a notified body.

A notified body may not be the manufacturer, the authorised representative, a supplier or their commercial competitor, nor offer or provide (or have offered or provided) consultancy or advice to any of these parties as regards the design, construction, marketing or maintenance of the products in question. However, this does not preclude the possibility of exchanging technical information and guidance between the manufacturer, the authorised representative, suppliers and the notified body.

To safeguard impartiality and avoid conflicts of interest it is important to make a clear distinction between conformity assessment performed by notified bodies prior to placing products on the market and market surveillance. Furthermore, market surveillance authorities must carry out their duties independently, impartially and without bias. Therefore, it is to be considered as inappropriate for market surveillance authorities to be designated as notified bodies, and the necessary safeguards should be put in place to ensure the impartiality and absence of conflict of interest if a single entity is entrusted with both responsibilities (251) (252). Notified bodies must have documented procedures for the identification, review and resolution of all cases where conflict of interest is suspected or proven. The notified body should also require all staff acting on its behalf to declare any potential conflict of interest.

Notified bodies must have under their control the necessary personnel, who have sufficient knowledge and experience relating to the products and conformity assessment procedure in question, and who have appropriate training. In particular, knowledge and experience should relate to relevant regulatory requirements and enforcement policies, European and international standardisation activities, relevant technologies, production methods and verification procedures, and normal conditions of use of the product in question. The body must be in a position to manage, control and be responsible for the performance of all its resources and maintain comprehensive records concerning the suitability of all the staff it uses in particular areas, whether they are employees, employed on contract or provided by external bodies. The body must also have access to appropriate facilities and be able to test or re-test in the EU. Otherwise it will not be possible for the notifying authority to check its competence.

Notified bodies must ensure the confidentiality of all the information it obtains in the course of conformity assessment. It must make adequate arrangements to ensure that no results or other information is disclosed to any other party than the competent authority in question, and to the manufacturer or the authorised representative.

Notified bodies must have adequate insurance to cover their conformity assessment activities. The scope and overall financial value of liability insurance must correspond to the level of risk linked with the activities of the notified body. The manufacturer in particular retains, however, the overall responsibility for the conformity of the product with all the requirements of the applicable legislation, even if some stages of the conformity assessment are carried out under the responsibility of a notified body.

Notified bodies are obliged to participate in coordination activities (253). They must also take part directly or be represented in European standardisation, or otherwise ensure that they know the situation of relevant standards (254).