5.3.4 ノーティファイドボディの能力の監視 – 一時停止 – 取消し – 不服申立て

It is essential to ensure that notified bodies remain competent over time and that this can be made transparent to the other Member States and the Commission. Legislation at EU level clearly requires the national competent authorities to regularly monitor and assess the continuing competence of the bodies they have notified and that are listed in NANDO. The NANDO web site should be transparent for these ongoing processes that back up the notification system.

All notifications of notified bodies, whether accredited or unaccredited, that are entered in the NANDO database, should be updated within a maximum period of five years from the date of the initial notification, or the last update, with information on the continuous monitoring of the competence of the notified body. Such updates should include the relevant new data relating to accreditation or, if the notification is unaccredited, information relating to the required monitoring of the body by the notifying authority - in particular, a report concerning the assessment process i.e. document review, on-site assessment, description of systematic surveillance including on-site visits and demonstration of the authority’s technical competence to conduct the assessment. If the notification is not updated after the 5 year period, the Commission will consider that there is reason to question the continued competence of the notified body (266) and will request the notifying Member State to provide with all information relating to the maintenance of the competence of the body concerned.

The Commission and the Member States have the responsibility to act when doubt arises about the competence of a notified body, either at the moment of notification or thereafter. Should the Commission consider, on its own initiative or after complaint, that a notified body does not comply with the requirements or fulfil its responsibilities, it will inform the national notifying authority and ask for appropriate documented evidence concerning the basis for the notification and the maintenance of the competence of the body. Should a Member State not provide such information, the Commission may bring this to the attention of the other Member States for discussion or initiate the procedure under Article 258 TFEU against the notifying Member State.

Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in the relevant legislation, or that it is failing to fulfil its obligations, the notifying authority must - depending on the seriousness of the failure - suspend or withdraw the notification after immediately contacting the body in question. It has to immediately inform the Commission and the other Member States accordingly. The Member State must also have this information published, and inform the Commission and the other Member States following a procedure similar to that of the notification. The body in question should have the possibility to appeal against such a decision. Whether this appeal postpones the de-notification or not depends on national legislation.

Withdrawal of notification takes place when the notified body ceases to fulfil the requirements or its obligations. This may be done at the instigation of the notifying Member State, where it has received evidence regarding the failure of the notified body to meet its requirements during the periodic surveillance (done by the accreditation body or the notifying authority), or has received complaints about the notified body’s competence or behaviour. It may also be a result of action by the Commission, where the latter has reason to doubt that a notified body meets or continues to meet the requirements for its notification. In such cases the Commission informs the notifying Member State accordingly and requests it to take the necessary corrective measures, including de-notification if necessary. The notifying authority must take appropriate measures. Another reason for withdrawal of a notification might be the request of the notified body itself, for instance due to planned changes in policy, organisation or ownership of the body. Withdrawal of a notification can also be the end result of an infringement procedure.

Withdrawal is the responsibility of the notifying Member State. Only the national authority is entitled to withdraw a notification. The Commission can withdraw a notified body from the NANDO list only when, at the end of an infringement procedure under Article 258 TFEU, the Court of Justice of the European Union declares a Member State to be in infringement of a given Union harmonisation act and, consequently, declares a notification to be invalid. In all such cases the Commission will ensure that any sensitive information obtained in the course of its investigations is treated confidentially.

Without prejudice to sectoral specificities, the suspension or withdrawal of a notification does not affect certificates issued by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn. In order to ensure continuity in the event of the suspension or withdrawal of a notification, or where the notified body has ceased its activity, the notifying Member State must ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.