---
title: "Technical Documentation — Definition | QbD Group"
description: "The structured evidence file a device or IVD manufacturer maintains to demonstrate conformity, as set out in MDR/IVDR Annexes II and III. It covers devi..."
url: https://qbdgroup.com/en/knowledge-center/glossary/technical-documentation
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Technical Documentation — Definition | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/technical-documentation"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# Technical Documentation

Regulatory Affairs

## Definition

The structured evidence file a device or IVD manufacturer maintains to demonstrate conformity, as set out in MDR/IVDR Annexes II and III. It covers device description, design and manufacturing information, risk management, verification and validation, clinical evidence, and post-market data.

technical file design dossier

## Related terms

[EU MDRThe European regulation governing the design, manufacture, and placing on the market of medical devices. It replaced the Medical Device Directive and tightened clinical evidence, technical documentation, traceability, and post-market surveillance requirements for all device classes.](https://qbdgroup.com/en/knowledge-center/glossary/eu-mdr)[IVDRThe European regulation for in vitro diagnostic medical devices. It introduced a risk-based classification (A to D), moved most IVDs under notified body oversight, and requires performance evaluation covering scientific validity, analytical performance, and clinical performance.](https://qbdgroup.com/en/knowledge-center/glossary/ivdr)[Notified BodyAn independent organisation designated by an EU member state to assess whether medical devices and IVDs meet regulatory requirements before CE marking. Its conformity assessment covers the quality management system, technical documentation, and ongoing surveillance audits.](https://qbdgroup.com/en/knowledge-center/glossary/notified-body)[CE MarkingThe manufacturer's declaration that a product complies with the applicable EU legislation and may be placed on the European market. For medical devices and IVDs it follows a conformity assessment, usually involving a notified body outside the lowest risk classes.](https://qbdgroup.com/en/knowledge-center/glossary/ce-marking)[MAAThe dossier submitted to EMA or a national authority requesting permission to market a medicinal product in Europe. It compiles quality, non-clinical, and clinical data in the Common Technical Document format, together with labelling and risk management documentation.](https://qbdgroup.com/en/knowledge-center/glossary/maa)[NDAThe application through which a sponsor asks the FDA to approve a new medicinal product for the United States market. It presents the full development package: chemistry and manufacturing, non-clinical safety, clinical efficacy and safety, and proposed labelling.](https://qbdgroup.com/en/knowledge-center/glossary/nda)

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