reg 9 Technical documentation and conformity assessment
Before placing apparatus on the market, a manufacturer must— (a) carry out a relevant conformity assessment procedure in respect of the apparatus or have such a procedure carried out; and (b) draw up— (i) the technical documentation referred to in Schedule 2 (module A: internal production control) or Schedule 3 (module B: EU- type examination and module C: conformity to type based on internal production control); and (ii) any other technical documentation required as part of the relevant conformity assessment procedure to demonstrate the means used by the manufacturer to ensure that the apparatus complies with the essential requirements.