Bharrgava Global
IVD Technical Documentation for the CE Marking
When lodging an application for device conformity assessment with a notified body, the application must include the device's technical documentation. This documentation describes the device's design, manufacture, and performance. While various documents from the device Design History File (DHF) constitute the core of the device's technical documentation, it must also include several IVD-R-specific documents:
To obtain the CE Marking in accordance with the In Vitro Diagnostic Regulation (IVDR) 2017/746, the following technical documents are required:
Summary of Technical Documentation (STED): This should comply with the requirements outlined in IVDR Annexes II and III.
General Safety and Performance Requirements (GSPR) Checklist: This must adhere to the guidelines specified in IVDR Annex I.
Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER): These documents should be prepared following the requirements set forth in IVDR Annex XIII.
Scientific Validity Report (SVR).
Analytical Performance Report (APR) and Clinical Performance Report (CPR): These reports should summarise the design and results of analytical and clinical performance studies. The CPR may also include clinical performance data gathered from a systematic review of scientific, peer-reviewed literature.
In addition, the technical documentation must include a description of the current state of the art (SOTA) for the device. And if your device is a Class C or Class D according to IVD-R Annex VIII, a Summary of Safety and Performance (SSP) must be provided.
In other words, it takes a lot of IVD-R knowledge, writing skills, and time before the device’s technical documentation is ready for submission to the notified body. It is a strict requirement that the technical documentation is clear, organized, readily searchable, and presented unambiguously.