In the fast-evolving world of medical diagnostics, the introduction of the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 has significantly changed how companies develop, test, and market their diagnostic kits in the European Union. The regulation officially came into force on May 26, 2022, replacing the outdated In Vitro Diagnostic Directive (IVDD). While the change has elevated the regulatory burden, it also aims to enhance patient safety and ensure the accuracy and reliability of diagnostic tools.
A key element of IVDR compliance is preparing IVD technical documentation—a comprehensive, structured set of data that demonstrates conformity with the regulation. This blog post provides a clear roadmap for how to prepare technical documentation for IVDs, especially diagnostic kits, while emphasizing important components such as clinical performance, scientific validity, and post-market activities.
📄 What Is IVD Technical Documentation?
Technical documentation under IVDR serves as evidence of compliance with all regulatory requirements and is critical for achieving CE marking and entering the EU market. It must reflect the entire lifecycle of the product—from design and development through to post-market surveillance.
The documentation should be detailed and specific to each device and must align with the General Safety and Performance Requirements (GSPRs) outlined in Annex I of IVDR. It includes product descriptions, manufacturing information, risk management files, and, most importantly, performance evaluation documentation.
Failure to provide complete and accurate technical documentation can result in delayed approvals or even removal from the market. For companies developing diagnostic kits, early and thorough preparation is crucial.
🎯 Clinical Performance Evaluation: The Heart of Technical Documentation
One of the most significant changes introduced by IVDR is the formalization and emphasis on performance evaluation. This goes beyond analytical testing and requires a multidimensional assessment of how well a device performs in a real-world clinical setting.
Under Annex XIII, performance evaluation is broken down into three essential components:
1. Scientific Validity
This refers to the association between the biomarker or analyte the device measures and a clinical condition. Scientific validity must be supported by peer-reviewed literature, well-established studies, or robust clinical data.
2. Analytical Performance
This is a measure of how reliably the device detects or quantifies the analyte under controlled conditions. It includes metrics like sensitivity, specificity, reproducibility, and limits of detection.
3. Clinical Performance
This involves assessing how the device performs in diagnosing or aiding in the diagnosis of a specific condition in real-world clinical environments. It must demonstrate that the diagnostic results are meaningful and clinically actionable.
All of this data culminates in a Performance Evaluation Report (PER)—a key deliverable that must be included in the IVD technical documentation. For detailed guidance on this topic, refer to this overview by Johner Institute.
🛠️ Roadmap for Preparing IVD Technical Documentation
Successfully compiling IVD technical documentation requires strategic planning and cross-functional collaboration between R&D, regulatory affairs, quality assurance, and clinical teams. Here’s a practical step-by-step roadmap:
Step 1: Classify the IVD Device
Use the IVDR classification rules (Annex VIII) to determine if the device falls into Class A, B, C, or D. The classification affects the extent of documentation and whether a notified body must be involved.
Step 2: Develop a Performance Evaluation Plan (PEP)
Before collecting data, outline a plan for how you will assess scientific validity, analytical performance, and clinical performance. This plan should specify the study design, intended population, and performance metrics.
Step 3: Conduct Performance Studies
Execute laboratory and clinical studies according to international standards such as ISO 20916:2019 for clinical performance. Ensure Good Clinical Practice (GCP) and appropriate ethical approvals.
Step 4: Compile the Performance Evaluation Report (PER)
Analyze the results of the studies and consolidate findings into the PER. This document should include justifications, conclusions, and any limitations, and will be a central pillar in the technical documentation.
Step 5: Establish a Post-Market Surveillance (PMS) Plan
Create a PMS plan to monitor ongoing performance after market launch. This includes periodic safety updates, post-market clinical follow-up (PMCF), and trending of complaints or adverse events.
Step 6: Assemble the Technical Documentation
Bring together all required elements into a single technical documentation file. Make sure it is organized and readily auditable by a notified body or regulatory authority.
✅ IVD Technical Documentation Checklist
Here is a concise checklist to ensure you are covering all required areas:
Device Description and Intended Purpose
Design and Manufacturing Information
Risk Management Documentation (ISO 14971)
Labeling and Instructions for Use
General Safety and Performance Requirements (GSPR) Checklist
Performance Evaluation Plan (PEP)
Performance Evaluation Report (PER)
Post-Market Surveillance Plan
Stability and Shelf-Life Data
UDI Assignment and EUDAMED Registration
Declaration of Conformity
This list can be adapted based on the device classification and intended use. For a detailed technical file structure, consult Trinity Med Consulting’s breakdown.
Mehrnaz Bozorgian
Mehrnaz Bozorgian, a Quality Assurance Specialist at Zamann Pharma Support, brings over 7 years of experience in international pharmaceutical compliance and related quality management systems. Specializing in audit and inspection topics, Mehrnaz's current goal is to focus more on Audit and Supplier Management to enhance the Zamann Service portfolio in this regard. Outside of work, she is an accomplished athlete holding a third-degree black belt in Taekwondo. With a passion for continuous improvement, Mehrnaz is an avid reader who enjoys exploring motivational and lifestyle enhancement resources. Connect with Mehrnaz on LinkedIn for insights into quality assurance and auditing.
