Division 3.8

The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the national authorities:

1. (a)

   the documentation referred to in point 3.5.1;

2. (b)

   the information relating to the change referred to in point 3.5.5, as approved;

3. (c)

   the decisions and reports of the notified body referred to in points 3.5.5, 3.6.3 and 3.6.4.