With the RoHS2 CE mark directive now capturing categories eight (medical devices) and nine (consumer monitoring and control instruments) there has been increased interest in the typical contents of an obligatory technical file:

Description of the electrical equipment including block diagrams

Wiring and circuit diagrams and explanations of what they mean

List of harmonised standards applied in full or in part

Records of risk assessments

Data sheets for critical sub-assemblies

Bill-of-materials / parts list

Copies of any markings and labels

Copy of user manual (maintenance, installation etc)

Test reports

….and the Declaration of Conformity