Article 45 Changes to notifications

This article deals with the consequences of a notified body falling short of its obligations — essentially, it is the enforcement mechanism that sits alongside the designation process established in Article 43.

Where a notifying authority becomes aware that a notified body no longer meets the required standards or is failing in its duties, it must take action by restricting, suspending, or withdrawing that body's notification, with the severity of the response calibrated to the seriousness of the failure.

The article also addresses the practical matter of what happens to the body's files and ongoing work if it loses its status or ceases operating entirely.

Important points:

• Notifying authorities are required to restrict, suspend, or withdraw a notified body's notification if it no longer meets the requirements of Article 39 or fails to fulfil its obligations, and must immediately inform the Commission and other Member States.
• The Commission and all Member States must be informed immediately when such action is taken.
• The notifying Member State must ensure that any files held by a restricted, suspended, withdrawn, or inactive notified body are either transferred to another notified body or kept available for the relevant authorities upon request.