Translation of "Benannte stelle" in English

Each Member State shall be entitled to change its designated body.

The notified body will give due consideration to the opinion of the EMEA when making its decision.

To this end, the manufacturer shall inform the notified body of the intended schedule of production.

The notified body shall carry out at least two visits during the first year of manufacturing.

Additionally, the notified body may pay unexpected visits to the manufacturer.

The notified body shall notify the competent authorities, the authority responsible for notified bodies and the Commission through the electronic system referred to in Article 57 of whether or not the procedure referred to in paragraph 1 of this Article is to be applied.

In choosing representative samples, the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 105 and in particular the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended purpose and the results of any previous relevant assessments such as with regard to physical, chemical, biological or clinical properties, that have been carried out in accordance with this Regulation.

Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier or less stringent than that of other notified bodies;

Nevertheless, the Agency may directly conduct additional inspections on any notified body, case by case.

Moreover, the notified body may pay the manufacturer unannounced visits.

Furthermore, the notified body may make unannounced visits to the manufacturer.

The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for medical devices in the Member States or the Commission.

The notified body shall participate in, or ensure that its assessment personnel is informed of, any relevant standardisation activities and in the activities of the notified body coordination group referred to in Article 49 and that its assessment and decision-making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.

In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annexes II and III.

The notified body shall review the clinical evidence presented by the manufacturer in the performance evaluation report and the related performance evaluation that was conducted.

At the time of such visits the notified body may conduct complete or partial audits.

In the event of frequent rejection of lots the notified body may suspend the statistical verification.