By Swetha Sankar | Tue Jul 1 2025 | 2 min read

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.

Topics

EU MDR

Speak to Our Compliance Experts

Questions about compliance, partnerships, or support? We're here to help.

Share

How to Prepare a Compliant Technical File Under IVDR (Annex II & III)

Annex II defines the core technical documentation (formerly “Technical File”) manufacturers must prepare—covering device description, design, performance data, risk management, benefit‑risk analysis, and evidence of GSPR compliance. Annex III mandates post-market surveillance (PMS) and performance follow-up (PMPF) plans and reports. Both annexes are required for CE marking under IVDR.
Manufacturers must compile eight key sections under Annex II: Device Description & Specification (with UDI, variants, classification) Information Supplied (labels, IFU, packaging, language compliance) Design & Manufacturing Processes (design stages, sites, suppliers) GSPR Mapping (Annex I cross-referenced evidence) Benefit‑Risk Analysis & Risk Management (ISO 14971-aligned) Product Verification & Validation (analytical and clinical performance data) Software validation & stability data (where applicable) Reference to previous versions or similar devices.
Annex III requires a structured post‑market surveillance and performance follow-up plan, including: Post‑Market Performance Follow-Up (PMPF) strategy Ongoing performance evaluation procedures Feedback and field safety corrective actions It ensures performance and safety are monitored after the device enters the market.
Analytical validation results must document specimen types, accuracy, precision, sensitivity, and test conditions. Clinical performance must reference studies or literature, particularly for Class C and D devices. Software, sterility, biocompatibility, stability, and usability validations must be documented. MDCG guidance confirms that documentation must support claims fully
Technical documentation must include a compliance matrix mapping each applicable GSPR clause from Annex I to: Rationale for its applicability or exclusion, Method of conformity demonstration (e.g. testing, clinical evaluation), Reference to harmonized standards or Common Specifications applied, Traceable cross‑references to supporting documentation in the file.
Yes, Annex II and III are required for all device risk classes (A–D), including Laboratory Developed Tests (LDTs) used within health institutions as per Article 5.5. Risk management, validation, and PMS documentation remain mandatory.
Generic or templated risk documents lacking device-specific detail Incomplete GSPR mapping or missing Annex I clauses Insufficient clinical or analytical data, especially for Class C/D devices No traceability between claims and evidence Inadequate PMS/PMPF planning or missing post-market metrics.