Regulation 11 Amendments to United Kingdom conformity approval

The manufacturer of equipment granted a conformity approval certificate by an approved body must notify that body of any changes that may affect the conformity of the equipment with applicable international standards or the conditions for validity of the certificate.

The manufacturer must notify the approved body that approved a quality system under regulation 10(1) of any intended changes to that system.

Following receipt of a notification under paragraph (1) or (2), the approved body must determine whether an amendment to the conformity approval certificate or to the approval of the quality system is required and notify the manufacturer accordingly.

Where an amendment to the conformity approval certificate or to the approval of the quality system is required, the manufacturer must apply in writing for the approval to be amended and provide such documents as requested by the approved body.