Division 7 The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicates that the approved type may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the product’s conformity with the essential requirements of this Regulation or the conditions for the certificate’s validity. Such modifications shall require additional approval and attached to the original EU-type examination certificate.