Technical Documentation under EU IVDR
General Background
The In-Vitro Diagnostic Regulation (IVDR) requires that manufacturers of in-vitro diagnostic medical devices provide comprehensive technical documentation to demonstrate the safety and performance of their devices. The technical documentation must include information on the design, development, production, risk management, and post-market surveillance of the device, as well as any relevant performance data. Additionally, manufacturers must have a quality management system in place that is compliant with the EU IVDR’s requirements. The technical documentation must be made available to the notified body and the competent authorities upon request.
This documentation must include:
- Device description
- Information to be supplied by the manufacturer
- Design and manufacturing information
- General safety and performance requirements (GSPR)
- Benefit-Risk Analysis and Risk Management
- Product Verification and Validation
- Post-market surveillance plan
- Post-market surveillance report or Periodic Safety Update Report
The technical documentation is required to be maintained throughout the device lifecycle and expected to be indexed using an aligned, structured format, as proposed in the position paper of the Team Notified Body (see https://www.team-nb.org), which helps to guide the reviewer and provide additional context to the relationship of documents within the technical documentation.
The content of the technical documentation will depend on the nature of the device. The technical must include a risk management file, which details the measures taken to mitigate potential risks associated with the device. Additionally, the EU IVDR requires manufacturers to maintain a post-market surveillance plan, which outlines the steps that will be taken to monitor the safety and performance of the device once it is on the market. It is intended to be a living document that is updated throughout the life cycle of the device.
Importantly, technical documentation shall be presented in a clear, organized, readily searchable and unambiguous manner. PDFs should be compiled ensuring optical character recognition (OCR) has been performed.
Under the EU IVDR, manufacturers shall keep the documentation available for competent authorities for 10 years after the last device has been placed on the market.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key points
Our Services
Training
AKRA TEAM offers training on drafting technical documentation to meet the expectation of EU IVDR and avoid common reasons for delays in technical documentation reviews by notified bodies.
Process and Templates Development
AKRA TEAM has proven procedure and document templates available for all aspects of the technical documentation including:
- Summary of technical documentation acc. to Team NB position paper
- Device description
- IFU and device labels
- Design and manufacturing documentation
- General Safety and Performance Requirements checklist
- Risk management file documentation
- Verification and validation documentation
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of technical documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of medical writers, clinicians and regulatory experts available to write all aspects of technical documentation for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer. Additionally, if the technical documentation is currently under review we can provide targeted updates based on any open deficiencies.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates and review of technical documentation. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of EU IVDR.
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