Regulation (EU) 2016/426 of the European Parliament and of the CouncilShow full title

2. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS

2.1. Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2.2, 2.3 and 2.4, and ensures and declares on his sole responsibility that the appliances or the fittings concerned are in conformity with the type described in the EU type-examination certificate and satisfy the requirements of this Regulation that apply to them.

2.2. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured appliances or fittings with the type described in the EU type-examination certificate and with the requirements of this Regulation that apply to them.

2.3. Product checks

A notified body, chosen by the manufacturer, shall carry out product checks or have them carried out at intervals of one year or less, in order to verify the quality of the internal checks on the appliance or the fitting, taking into account, inter alia, the technological complexity of the appliances or the fittings and the quantity of production. An adequate sample of the final appliances or fittings taken on site by the notified body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the harmonised standards, and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to check the conformity of the appliance or the fitting with the relevant requirements of this Regulation. Where a sample does not conform to the acceptable quality level, the notified body shall take appropriate measures.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the appliance or the fitting performs within acceptable limits, with a view to ensuring conformity of the appliance or the fitting.

The manufacturer shall, under the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.

2.4. CE marking and EU declaration of conformity

2.4.1. The manufacturer shall affix the CE marking to each individual appliance or fitting that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation.

2.4.2. The manufacturer shall draw up a written EU declaration of conformity for each appliance or fitting model and keep it at the disposal of the national authorities for 10 years after the appliance or fitting has been placed on the market. The EU declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

2.5. Authorised representative

The manufacturer's obligations set out in point 2.4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.