EU-AIA-36-02 Requirement 36 — Changes to notifications

Apply Articles 29-30 procedures for scope extensions

Description

Where changes to notification involve extensions of the scope of the notification, the procedures laid down in Articles 29 and 30 must be applied.

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Notify Commission and Member States of changes to notified body notification

Notified body must inform of cessation of conformity assessment activities

Successor notified body must confirm assumption of responsibility and complete assessment

Notifying authority must withdraw designation upon cessation

Notifying authority must investigate failing notified bodies without delay

Notifying authority must inform notified body of objections and allow response

Notifying authority must restrict, suspend or withdraw non-compliant designation

Notifying authority must immediately inform Commission and Member States of designation changes

Notified body must inform providers within 10 days of designation suspension/withdrawal

Notifying authority must preserve and share notified body files

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