The manufacturer must undertake to fulfil the obligations arising out of the quality assurance system as approved and to maintain it in an adequate and efficient manner.

The manufacturer or his authorised representative established within the Community shall keep the notified body that has approved the quality assurance system informed of any intended updating of the quality assurance system.

The notified body must evaluate the modifications proposed and decide whether the modified quality assurance system will still satisfy the requirements referred to in point 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.