The technical documentation is the manufacturer's documentation for the medical device, the safety and performance for the device.
What is technical documentation
The technical documentation, including the clinical documentation, is the manufacturer's documentation of the device, its safety and performance. The documentation shall include information of the manufacturing, design, testing, risk management and clinical evaluation of the device. The technical documentation shall make it possible to evaluate whether the device meets the requirements of the regulation.
The technical documentation, including the clinical documentation, shall be drawn up for all medical devices, regardless of the risk classification and whether it is assessed by a notified body or not.
Annex II of MDR and IVDR describes the information what the technical, including clinical, documentation shall contain. The documentation shall demonstrate that the device fulfills the general safety and performance requirements as they are described in Annex I in MDR and IVDR. The technical documentation shall include information from post- market surveillance. This is described in annex III of MDR and IVDR.
Requirements for specific types of devices
There are specific requirements for the documentation of certain types of devices.
MDR includes distinct requirements for devices which:
- Incorporate substances consideres to be medicinal products
- Are manufactures utilising tissues or cells of human or animal origin, or their derivatives, or contain such substances.
- Are composed of substances or combinations of substances that are absorbed by or locally dispersed in the human body.
IVDR includes specific requirements which are applicable for devices which are used for self-testing and near patient testing.
For implantable devices and for class III devices, and for class C and D IVD-devices, a Summary of safety and (clinical) performance shall be drawn up. The summary shall be written in a way that is clear to the intended user and, if relevant, to the patient.