Technical Documentation (MDR)
The comprehensive set of documents that a manufacturer must compile to demonstrate a medical device's compliance with EU MDR requirements. Technical documentation includes design specifications, risk analysis, clinical evaluation, biocompatibility data, labeling, and instructions for use.
Technical documentation (also called a Technical File for Class I devices or a Design Dossier historically) is the complete body of evidence that demonstrates a medical device meets all applicable General Safety and Performance Requirements (GSPRs) under EU MDR 2017/745. It must be compiled before a device can undergo conformity assessment.
Required contents
EU MDR Annexes II and III define the required contents: device description and specification, design and manufacturing information, General Safety and Performance Requirements checklist, risk management documentation (per ISO 14971), clinical evaluation report, biocompatibility assessment, verification and validation results, labeling and instructions for use, and post-market surveillance plan.
Tender documentation requirements
While procurement teams do not review the full Technical Documentation, they may request specific elements such as the Declaration of Conformity, Summary of Safety and Clinical Performance (SSCP), or IFU. Understanding what sits in the Technical File helps tender response teams quickly locate evidence for compliance claims.