Division 6.1

Changes to the approved device must receive further approval from the notified body which issued the EC type-examination certificate wherever the changes may affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the device. The applicant shall inform the notified body which issued the EC type-examination certificate of any such change made to the approved device. This new approval shall take the form of a supplement to the initial EC type-examination certificate.