Division 3.3.1 The manufacturer must lodge an application for approval of his quality system with a notified body of his choice for the appliances in question.

The application must include:

• the quality system documentation,

• an undertaking to carry out the obligations arising from the quality system as approved,

• an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness,

• documentation relating to the approved type and a copy of the EC type-examination certificate.