Commission Delegated Regulation (EU) 2019/945Show full title

PART 10 U.K. Contents of the technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the product's conformity to the applicable requirements.

The technical documentation shall, wherever applicable, contain at least the following elements,:

1.

a complete description of the product including:

(a)

photographs or illustrations showing its external features, markings and internal layout;

(b)

the versions of any software or firmware involved in compliance with the requirements set by this Regulation;

(c)

user's manual and installation instructions;

2.

conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;

3.

descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

4.

a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements set out in Article 4, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;

5.

copy of the EU declaration of conformity;

6.

where the conformity assessment module in Part 8 has been applied, copy of the EU type examination certificate and its annexes as delivered by the notified body involved;

7.

results of design calculations made, examinations carried out, and other relevant similar elements;

8.

test reports;

9.

copies of the documents that the manufacturer has submitted to the notified body if any involved;

10.

the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility;

11.

addresses of places of manufacture and storage.