5.3.2 ノーティフィケーションのプロセス

The status of Notified Body is available to conformity assessment bodies established within the European Union. Member States are responsible for the notification of notified bodies and the choice of and responsibility for notified bodies rests with national authorities. They may choose the bodies they notify from those that are established on their territory which comply with the requirements of the legislation, and which have the necessary competences to become notified. Notification is the act of the notifying authority informing the Commission and the other Member States that such a body has been designated to carry out conformity assessment according to a Union harmonisation act, and fulfils the requirements relating to notified bodies set out in that Union harmonisation act.

While designation is considered as an act of the designating authority – which may be the same body as the notifying authority – only the act of notifying the Commission and the other Member States allows a ‘designated body’ to become a ‘notified body’.

Since notification falls within the discretion of Member States, they are not obliged to notify all the bodies demonstrating technical competence. Neither are Member States obliged to notify bodies in respect of each procedure to be applied according to a specific Union harmonisation act.

Member States are free to notify a body at any time after a Union harmonisation act has been adopted. They should nevertheless take all necessary steps for notifying before the Union harmonisation act starts applying (259) and ensure harmonised competences across all notified bodies. This can make effective use of the transitional period provided for in the Union harmonisation act, and allow for notified bodies to be active and certificates to be granted from the date of first application of the Union harmonisation act. If on the basis of new legislation the re-notification of notified bodies is required, as soon as the Member State has transposed the necessary provisions into national law and has appointed a notifying authority for a particular Union harmonisation act, it is possible for that notifying authority to place a notification. A notified body may thus be notified under both the old and the new legislation during the transitional period, but the notification under the old legislation will expire automatically on the date of application of the new legislation, unless specific legislation provides otherwise. It must be stressed, however, that in such cases notified bodies, while they can do preparatory work, are not entitled to issue certificates before the Union harmonisation legislation starts applying unless sector legislation provides otherwise.

The assessment of a conformity assessment 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.

Member States take the final responsibility for the competence of their notified bodies with respect to the other Member States and the EU institutions. They must therefore verify the competence of the bodies seeking notification, based on the criteria laid down in the applicable Union harmonisation legislation in conjunction with essential requirements and the conformity assessment procedure(s) in question. In general, the competence criteria set out in the Union harmonisation acts cover:

—availability of personnel and equipment;

—independence and impartiality in relation to those directly or indirectly concerned with the product (such as the designer, the manufacturer, the manufacturer’s authorised representative, the supplier, the assembler, the installer, the user);

—technical competence of personnel that is relevant to the products and conformity assessment procedure in question;

—maintenance of professional secrecy and integrity; and

—subscription to civil liability insurance, unless that liability is covered by the state under national law.

Notifying authorities or accreditation bodies must carry out periodic monitoring to assess the continuity of the competence of notified bodies after they are notified.

Notified Bodies may have activities or personnel outside the Member State where they are legally established, or even outside the Union. However, the notifying authority of this Member State must be capable of ensuring the monitoring of the whole Notified Body (not only the head office). Having all the testing facilities in another Member State or even outside the EU would make it almost impossible for the notifying authority to monitor the operations of the whole Notified Body.

The supervision of multi-site conformity assessment bodies is done under the cross-border cooperation among the national accreditation bodies and notifying authorities; however, the responsibility remains with the notifying authority of the Member State in which the conformity assessment body is established. The conformity assessment body as the main entity to be notified must have itself the means and the competence to carry out the tasks required for the notification. While it may have recourse to subsidiaries/subcontracting, it should not rely for all test and evaluations on subsidiaries/subcontractors (260).

The notified body may subcontract specific tasks connected with the conformity assessment, has to ensure that the subcontractor meets the same requirements that are applicable to the notified body itself and may subcontract specific activities only with the agreement of the client. Thus, structures where the head office of the candidate-notified body in the Member State of notification consists of very few staff performing only commercial tasks but none of the conformity assessment tasks for which the body is (to be) notified would be carried out in that Member State, cannot be accepted.

Accreditation, performed according to the EN ISO/IEC 17000 series of standards by nationally recognised accreditation bodies that are members of the European co-operation for Accreditation (EA), is a technical assessment of the competence of the conformity assessment body seeking notification. Although it is not a requirement, it remains an important and favoured instrument for evaluating the competence and integrity of the bodies to be notified. For this reason, accreditation should be considered by national notifying authorities as the most favoured technical basis for the assessment of conformity assessment bodies so as to reduce differences in the criteria applied for notification.

The harmonised standards of the EN ISO/IEC 17000 series that can be used to demonstrate the competence of the candidate notified body may vary depending on the specific conformity assessment tasks (modules) and the different products in Union harmonisation legislation. In order to ensure harmonisation of the assessment of competence of candidate notified bodies, the European Cooperation for Accreditation (EA) has developed a recommendation on standards for accreditation for each relevant Union harmonisation legislation and for each conformity assessment module (261). It is intended to apply to all National Accreditation Bodies that assess and accredit conformity assessment bodies for notification purposes, unless the notifying and/or regulating authority - at its own discretion - has officially established and published different requirements.

Accreditation provides an authoritative statement of the competence, professional integrity and impartiality of the bodies to be notified to the Commission and the other Member States. For a notification to be considered as accompanied by an accreditation certificate, the accreditation certificate must indicate the competence of the candidate notified in relation to the specific Union harmonisation legislation for which notification is being sought. Accreditation also entails regular monitoring and surveillance of the accredited bodies. Whenever a national accreditation body ascertains that the conformity assessment body to which it has issued an accreditation certificate is no longer competent or does not fulfil its obligations, the accreditation certificate must be withdrawn. In this case the body should be de-notified and no longer allowed to carry out conformity assessment activities under the relevant legislation.

The preference given to accreditation is based on the peer evaluation process which ensures that the accreditation body adequately supervises the conformity assessment bodies it accredits. Cases may, however arise where the national accreditation body has not been successfully peer evaluated but may nevertheless have assessed notified bodies (262). If the national accreditation body has not been peer evaluated for the specific accreditation activity in question but still evaluate the competence of a conformity assessment body for this activity, the notification of this conformity assessment body should not be considered as accredited for the purposes of EU harmonisation legislation.

If a national accreditation body was successful in a previous peer evaluation for a given activity but has been suspended at a subsequent peer evaluation, new notifications of conformity assessment bodies assessed by this national accreditation body should also be considered as unaccredited. As a principle, accreditation certificates issued up until the point of the suspension of the peer evaluation of the national accreditation body, should continue to be recognised by national authorities.

If the grounds for suspension of the national accreditation body result in serious doubts about the competence of the notified bodies, the responsible notifying authority would have to inform the Commission and other Member States of how it intends to ensure the competence of the bodies notified, and of any corrective measures taken, including the de-notification.

Although accreditation is the favoured instrument for the verification of competence of conformity assessment bodies, Member States can carry out the evaluation themselves. Following the entry into force of Regulation (EC) No 765/2008 on 1 January 2010, in such cases evidence must be given to the Commission and other Member States that the evaluated body complies with all the applicable regulatory requirements. Further, the notified body must be subject to regular surveillance similar to the practice established by the accreditation organisations.

According to Article 5(2) of Regulation (EC) No 765/2008, when a Member State does not base its notification on accreditation, ‘it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Union harmonisation legislation in question’ (263).

In order to ensure the necessary level of confidence in the impartiality and technical competence of conformity assessment bodies and in the reports and certificates issued by them, national authorities, when carrying out the assessment without accreditation, should give detailed and comprehensive information describing how the candidate Notified Body has been assessed as qualified to carry out the tasks for which it is notified and showing that it fulfils the applicable criteria relating to notified bodies. This information, linked to a given notification, is made available to the Commission and the other Member States using the NANDO electronic notification tool.

The evaluation procedure should be based on at least the following elements:

—a formal application procedure

—assessment against applicable requirements.

—production of an assessment report

—clear decision-making process

—existence of a systematic surveillance and related sanction mechanism, providing for periodic surveillance including on-site visits, in order to verify the continued fulfilment of requirements by the notified body

—demonstration of the national authority’s own technical competence for assessing conformity assessment bodies for the purpose of notification under technical harmonisation legislation. This demonstration must give equivalent assurance as the EA (264) peer evaluation system.

—the candidate notified bodies should be made aware of general conditions, of their rights and obligations, and of the requirements relating to assessment carried out with a view to notification

The assessment itself should consist of:

—a review of documents verifying the completeness and appropriateness from a substantial point of view with regard to conformity to the applicable requirements

—an on-site audit to check technical and procedural aspects - such as the availability and appropriateness of facilities and equipment, the technical competence of staff, the existence of an appropriate management system - and to check other aspects demonstrating that conformity to requirements is properly implemented. The assessment must include witnessing technical activities.

When choosing an assessment process other than formal accreditation, notifying authorities must indicate the reasons why accreditation is not chosen to back up the notification process. Moreover, notifying authorities may not outsource to the national accreditation body the assessment of unaccredited conformity assessment bodies that seek to become notified bodies, without fulfilling the whole accreditation process including the delivery of the accreditation certificate.

When accreditation is not used, the notifying authorities must perform periodical verifications to ensure the continuous competence of the notified body, in the same way as national accreditation bodies do.

To obtain notification, a conformity assessment body submits an application for notification to the notifying authority of the Member State in which it is established. That application should be accompanied by a description of the conformity assessment activities, the conformity assessment procedures or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by the national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in the relevant harmonisation legislation.

Where the body concerned cannot provide an accreditation certificate, it must provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in the relevant harmonisation legislation. After verification the Member State informs the Commission and the other Member States of the details of the body.

The notification of a notified body is sent by the notifying authority to the Commission and the other Member States via NANDO (New Approach Notified and Designated Organisations), which is an electronic notification tool developed and managed by the Commission. It should include full details of the body, its conformity assessment activities, the conformity assessment procedures or modules and product or products concerned, and the relevant attestation of competence. It must also include the date set for the reassessment of the notified body by the national accreditation body or, for an unaccredited notification, the date of the next monitoring review by the notifying authority.

Where a notification is not based on an accreditation certificate, the notifying authority must provide the Commission and the other Member States with documentary evidence which demonstrates the conformity assessment body’s competence, how it has been assessed, and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements.

The notification takes effect after a notification email from NANDO has been sent to the Commission and the other Member States and published on the NANDO web site. The body concerned may then perform the activities of a notified body. Under legislation that is aligned with Decision No 768/2008/EC, the notification is published following a period allowed for objections by other Member States or the Commission - two weeks where accreditation is used, two months where accreditation is not used - and then only where no such objections have been raised.

The Commission and the other Member States must be notified in similar manner of any subsequent changes to the notification that are relevant, such as a change in the scope or validity period of the notification, or changes to the details of the body itself.