IVD Technical Documentation

Qarad can support the writing and compilation of IVD-R-compliant technical documentation in line with your notified body’s specific expectations.

Key Components of Technical Documentation for IVD-R Compliance

When lodging an application for device conformity assessment by a notified body, the application must include the technical documentation of the device. The technical documentation describes the design, manufacture, and performance of the device. While various documents from the device Design History File (DHF) constitute the core of the device technical documentation, it must also include several IVD-R-specific documents:

  • Summary of Technical Documentation (STED), in accordance with IVD-R Annexes II and III
  • General Safety and Performance Requirements (GSPR) checklist, in accordance with IVD-R Annex I
  • Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) in accordance with IVD-R Annex XIII
  • Scientific Validity Report (SVR)
  • Analytical Performance Report (APR) and Clinical Performance Report (CPR), summarizing the design and results of the analytical and clinical performance studies The CPR may include device clinical performance, as retrieved from a systematic review of the 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.

Why Qarad?

At Qarad, we have medical writers with extensive experience covering a large range of technologies and clinical fields. They are dedicated experts in clinical evidence (scientific validity, analytical performance, and clinical performance) and IVD-R-specific technical documentation.

Our pragmatic approach and tailored service have proven time and again to be successful and are recognized by notified bodies. While our consultants can guide you to work towards first-time-right technical documentation submissions by providing regulatory advice, training, or reviewing of technical documentation, you can also rely on Qarad to do the work for you. We write (parts of) the technical documentation using your or our templates, as desired.

We can write a specific set of documents or provide a submission-ready full technical documentation. Our systematic methodologies and processes ensure high quality and consistent documentation, ready to pass the test of your notified body!

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