Division 6.1

F1The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:

• the declaration of conformity,

• the documentation referred to in the fourth indent of Section 3.1F2 and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,

• the changes referred to in Section 3.4,

• the documentation referred to in Section 4.2, and

• the decisions and reports from the notified body as referred to in Sections 3.3, 4.3, 4.4, 5.3 and 5.4.