PART 2Prohibitions and Obligations on Economic Operators
Manufacturers and their authorised representatives
Conformity assessment procedure and drawing up of technical documentationE112
1
A manufacturer must—
a
draw up technical documentation; and
b
carry out, and comply with their obligations under, the internal production control procedure,
in relation to the EEE, in line with F1Part 4 of Schedule 1.
2
Where other applicable F2retained EU law requires the EEE to be subject to a conformity assessment procedure which is at least as stringent as that required under paragraph (1), compliance with the requirements of regulation 3 may be demonstrated within the context of that procedure and a single set of technical documentation may be drawn up.
Conformity assessment procedure and drawing up of technical documentationE212
1
A manufacturer must—
a
draw up technical documentation; and
b
carry out, and comply with their obligations under, the internal production control procedure,
in relation to the EEE, in line with Module A of Annex II to Decision 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and repealing Council Decision 93/465/EEC.
2
Where other applicable EU legislation or legislation giving effect to EU legislation requires the EEE to be subject to a conformity assessment procedure which is at least as stringent as that required under paragraph (1), compliance with the requirements of regulation 3 may be demonstrated within the context of that procedure and a single set of technical documentation may be drawn up.