Table of Contents
If you're placing in vitro diagnostic (IVD) devices on the EU market, your technical documentation is the backbone of compliance. Under Regulation (EU) 2017/746 (IVDR), Annex II and Annex III define a far more structured and prescriptive format for technical files compared to the previous IVDD.
This isn’t just a paperwork upgrade, it’s a complete shift in how manufacturers must demonstrate conformity, manage post-market obligations, and prepare for Notified Body review.
Let’s walk through what you need and what’s changed.
What Is the IVDR Technical File?
The technical file (or technical documentation) is the full set of evidence that shows your device meets IVDR requirements, including safety, performance, and risk control.
It’s mandatory for:
- All IVD device classes (A through D)
- All economic operators involved in design, manufacturing, or distribution
- Submission to Notified Bodies (for Class B, C, D)
IVDR makes no room for ambiguity. Annex II defines what must be included—and Annex III outlines what must be updated after market entry.
##Annex II — Technical Documentation Requirements
Annex II of IVDR breaks down into eight detailed sections:
1- Device Description and Specification
- Basic UDI-DI, trade name, and intended use
- Risk classification and justification (based on Annex VIII)
- Device variants and accessories
- Design features and principles
Be clear and precise—intended use directly impacts your classification and conformity route.
2- Information Supplied with the Device
- Labels, Instructions for Use (IFU), packaging artwork
- Languages for each Member State
- Required content for user safety and performance
All documents must align with GSPR (Annex I) and support safe use by lay users or professionals.
3- Design and Manufacturing Information
- Design stages, development history
- Manufacturing process, production controls
- Site details and subcontractor roles
Even outsourced processes must be documented—transparency is non-negotiable.
4- General Safety and Performance Requirements (GSPR) Checklist
- Complete mapping of your device’s compliance with Annex I
- Cross-referenced evidence for each applicable requirement
Most Notified Bodies expect this in a tabulated matrix with links to supporting documentation.
5- Benefit-Risk Analysis and Risk Management
- Process documentation (ISO 14971-aligned)
- Hazard identification, risk evaluation, and control measures
- Residual risks and their acceptability
Show your logic. Risk acceptability without mitigation is a red flag.
6- Product Verification and Validation
- Analytical and clinical performance studies
- Software validation (if applicable)
- Electrical safety, EMC, biocompatibility
- Sterilization, shelf life, packaging integrity
Performance Evaluation Report (PER) results must be cited here.
7- Labeling Requirements
- Confirmation that labels meet UDI, traceability, and EU language obligations
- Graphic symbols, where used, must be standardized or explained
Your labeling must include the "IVD" designation and clear safety warnings.
8- Quality Management System
- Procedures governing design, manufacturing, PMS, and reporting
- Responsibilities of PRRC (Person Responsible for Regulatory Compliance)
Even for Class A devices, the QMS must cover key IVDR functions.
Annex III — Post-Market Surveillance & PMPF
Unlike IVDD, IVDR mandates ongoing technical documentation through Annex III, which introduces:
- 1 PMS Plan
- Systematic process to collect and analyze data from the field
- Must align with the risk class and intended use
- Includes vigilance, complaints, recalls, and trend reports
No PMS plan = no compliance. This is a living document updated regularly.
- 2 Post-Market Performance Follow-up (PMPF) Plan
- Continuous evaluation of performance data post-market
- PMPF studies, surveys, trend monitoring, registry access
- Required for Class C and D, strongly recommended for others
Evidence feeds directly into your PER updates, GSPR revalidation, and PSUR.
- 3 PMS Report / PSUR
- Class A & B: PMS report summary available upon request
- Class C & D: PSUR updated annually or biennially, submitted to Notified Body
Non-compliance with PSUR timelines may result in certificate suspension.
Common Technical File Mistakes Under IVDR
- Submitting outdated documentation from the IVDD era
- Using generic risk assessments not tailored to the device
- Incomplete PER or missing PMPF justifications
- Labeling that doesn’t comply with language or symbol requirements
- No GSPR checklist or cross-referenced evidence
Pro Tip: Notified Bodies now perform systematic sampling of technical files—even after certification. There’s no room for shortcuts.
How Acquis Helps You Stay Audit-Ready
Acquis streamlines the creation and maintenance of IVDR technical files with:
- Automated GSPR & Annex II structure templates
- Linked evidence tracking for all performance claims
- Supplier data integration for full material traceability
- PMS/PSUR workflows and real-time updates
- Audit-mode documentation export for Notified Bodies
Book your IVDR documentation readiness assessment and reduce your technical file prep from months to weeks.