ANNEX IVU.K.CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN ARTICLE 10(5)(Technical construction file)
This Annex consists of Annex III plus the following supplementary requirements:
The technical documentation described in point 4 of Annex II and the declaration of conformity to specific radio test suites described in Annex III must form a technical construction file.
The manufacturer, his authorised representative established within the Community or the person responsible for placing the apparatus on the market, must present the file to one or more notified bodies, each of the notified bodies must be informed of others who have received the file.
The notified body must review the file and if it is considered that it has not been properly demonstrated that the requirements of the Directive have been met, the notified body may issue an opinion to the manufacturer, his representative or the person responsible for placing the apparatus on the market and must inform the other notified bodies who have received the file accordingly. Such an opinion must be given within four weeks of receipt of the file by the notified body. On receipt of this opinion, or after the end of the four-week period, the apparatus may be placed on the market, without prejudice to Articles 6(4) and 9(5).
The manufacturer or his authorised representative established within the Community or the person responsible for placing the apparatus on the market must keep the file for a period ending at least 10 years after the last apparatus has been manufactured at the disposal of the relevant national authorities of any Member States for inspection.