Medical device directives require the manufacturer of the product to create a technical file containing the information required to show that the product complies with the requirements of the directives for CE Marking.
Whilst the directives contain general details of the sort of information which will be required in the technical file, this information is general and high level / non prescriptive. Typically, the following minimum items should be included:
- – Design specifications / Design File
- – Description of the apparatus, usually accompanied by block diagram
- – Wiring and circuit diagrams
- – General Arrangement drawing
- – List of standards applied
- – Records of risk assessments and assessments to standards
- – Description of control philosophy/logic
- – Datasheets for critical sub-assemblies
- – Part list
- – Copies of any markings and labels
- – Copy of instructions (user, maintenance, installation)
- – Test reports
- – Quality control & commissioning procedures
- – Declaration of Conformity
Additional information may include copies of the engineering drawings for any bespoke parts. However, this additional information should not be used to pack the file at the expense of the more relevant information on how the equipment operates and how it meets the safety objectives of the Directives.
It should be noted that simple products will require less information in the corresponding technical file as opposed to more complex or medical devices.