Technical document under IVDR 2017/746

IVD Technical Documentation Made Simple
IVD technical documentation is basically the master evidence file that proves your device meets IVDR requirements for safety, performance, and quality. Under IVDR 2017/746, you must prepare it before you place the device on the EU market and keep it updated for the whole life of the product because regulators and notified bodies expect it to reflect the latest design changes, risk updates, and post-market findings. IVDR splits the technical file into two main parts. Annex II is the “core file” (pre-market + design evidence): device description and intended purpose, labeling/IFU, design and manufacturing information, a GSPR checklist showing how you meet Annex I requirements, risk management and benefit risk evidence (often ISO 14971-based), and verification/validation including analytical and clinical performance data and stability/shelf-life. In short, Annex II answers: What is the device, how is it made, and what proof shows it works and is safe? Annex III is the “post-market section” (life-after-launch evidence). It includes your PMS Plan (how you will collect and analyze complaints, incidents, feedback, literature, trends), and your required outputs: PMS Report (PMSR) for lower-risk devices (often Class A/B) or a PSUR for higher-risk devices (Class C/D, and sometimes B depending on interpretation and NB expectations). If needed, it also includes PMPF documents planned activities to keep confirming performance in real-world use. Annex III answers: How will you continuously monitor the device and react if issues appear? The key beginner rule: your technical documentation must work like a closed loop. Post-market data (PMS/PMPF/vigilance) should feed back into risk management, performance evaluation, IFU/labels, CAPA, and change control. If you keep it organized, traceable, and version-controlled, you make audits much easier and you protect the CE mark by showing ongoing compliance, not just a “one-time” submission.

IVD Technical Documentation Made Simple

IVD technical documentation is basically the master evidence file that proves your device meets IVDR requirements for safety, performance, and quality. Under IVDR 2017/746, you must prepare it before you place the device on the EU market and keep it updated for the whole life of the product because regulators and notified bodies expect it to reflect the latest design changes, risk updates, and post-market findings.

IVDR splits the technical file into two main parts. Annex II is the “core file” (pre-market + design evidence): device description and intended purpose, labeling/IFU, design and manufacturing information, a GSPR checklist showing how you meet Annex I requirements, risk management and benefit risk evidence (often ISO 14971-based), and verification/validation including analytical and clinical performance data and stability/shelf-life. In short, Annex II answers: What is the device, how is it made, and what proof shows it works and is safe?

Annex III is the “post-market section” (life-after-launch evidence). It includes your PMS Plan (how you will collect and analyze complaints, incidents, feedback, literature, trends), and your required outputs: PMS Report (PMSR) for lower-risk devices (often Class A/B) or a PSUR for higher-risk devices (Class C/D, and sometimes B depending on interpretation and NB expectations). If needed, it also includes PMPF documents planned activities to keep confirming performance in real-world use. Annex III answers: How will you continuously monitor the device and react if issues appear?

The key beginner rule: your technical documentation must work like a closed loop. Post-market data (PMS/PMPF/vigilance) should feed back into risk management, performance evaluation, IFU/labels, CAPA, and change control. If you keep it organized, traceable, and version-controlled, you make audits much easier and you protect the CE mark by showing ongoing compliance, not just a “one-time” submission.

Introduction

In-vitro diagnostic (IVD) technical documentation is the backbone of regulatory compliance under the EU IVDR 2017/746. It serves as evidence that an IVD device meets safety, performance, and quality requirements throughout its lifecycle. This comprehensive set of documents spans the product’s design, manufacturing, clinical evidence, risk management, and post-market surveillance strategies.

According to Annex II of the IVDR, manufacturers must compile documentation before placing the device on the EU market, ensuring it remains up-to-date and manufacturers must establish and maintain this documentation to secure and maintain CE marking and to pass conformity assessment with notified bodies.

What Is Technical Documentation under IVDR?

Technical documentation is the comprehensive file that demonstrates an IVD’s conformity with IVDR.
It covers every stage of the device lifecycle—from design and intended purpose to manufacturing, validation, and post-market follow-up.

Legal basis:
- Article 10(4): obliges manufacturers to prepare technical documentation before placing a device on the market.
- Article 10(9): requires that documentation follow Annex II and Annex III and remain available for inspection by competent authorities or notified bodies.

it is a living document that must be actively updated.

Structure of Technical Documentation

IVDR divides technical documentation into two primary parts.

Annex II – Technical Documentation (Core File) from Annex II (Points 1 to 6), IVDR 2017/746.

Section	Description
Device Description & Specification	Intended purpose, risk class (A to D), device group/category, principles of operation, critical raw materials, software or algorithms if used.
Information Supplied with the Device	Labels, symbols, and Instructions for Use (IFU). Must meet Annex I, Chapter III language and readability rules.
Design & Manufacturing Information	Flow of manufacturing processes, drawings, specifications, supplier controls, and site details.
General Safety & Performance Requirements (GSPRs)	Evidence cross-referencing each Annex I requirement, including chemical, biological, and microbiological safety, performance characteristics, and packaging integrity.
Benefit–Risk Analysis & Risk Management	Documented according to ISO 14971, with linkage to the performance evaluation plan and PMS results.
Product Verification & Validation	Includes analytical and clinical performance reports, stability and shelf-life studies, software verification/validation, and usability engineering where relevant.

Annex III – Technical Documentation on Post-Market Surveillance (PMS)

Annex III of Regulation (EU) 2017/746 (IVDR) sets the post-market requirements that complement the design and pre-market evidence contained in Annex II. While Annex II proves initial conformity, Annex III ensures that an IVD continues to meet the General Safety and Performance Requirements (GSPRs) throughout its life cycle. This is critical because real-world use often reveals new risks, performance trends, or user issues that may not surface in pre-market testing.

Under Article 10(9), manufacturers must prepare and keep up to date the PMS documentation described in Annex III and integrate it into the overall technical file.

PMS Plan – The Core Roadmap

The PMS Plan is the blueprint for continuous monitoring of the IVD device after it is placed on the market.

It should be device specific and proportionate to the risk class, intended purpose, and complexity of the product.

Key elements to document:

Area	Description
Data Collection & Sources	Complaint logs, customer feedback, user surveys, literature reviews, vigilance databases, distributor reports, trend analysis from EUDAMED, and competitor information.
Methodology	Statistical techniques for trend detection, frequency of reviews, and defined thresholds for action.
Responsibilities & Roles	Named personnel and links to the company’s QMS procedures (ISO 13485).
Corrective/Preventive Actions (CAPA)	How identified risks will trigger corrective or preventive measures.
Integration with Risk Management	Alignment with the ISO 14971 risk management file and Performance Evaluation Plan (PEP).
Report Generation	Clear link to PMS Report (Class A) or PSUR (Class B to D).

Regulatory Reference: Annex III Section 1(a), IVDR 2017/746.

PMS Report For Class A Devices

For Class A non-sterile devices, IVDR allows a simplified output known as the PMS Report.

Content: Summary of PMS activities, key findings, complaints, CAPA actions, and any trend reporting.
Frequency: Must be updated as needed and made available to competent authorities upon request (not automatically submitted).
Purpose: Demonstrates that even low-risk IVDs remain safe and perform as intended.

Reference: Annex III Section 1(b) and Article 80.

Periodic Safety Update Report (PSUR) – For Class B, C, and D Devices

The Periodic Safety Update Report (PSUR) is a regulatory requirement under the EU In Vitro Diagnostic Regulation (IVDR).

It applies to higher-risk IVD devices (Class B, C, and D).
The PSUR is a more detailed and comprehensive document than the regular Post-Market Surveillance (PMS) report.

Frequency of Submission:

The table specifies how often manufacturers must prepare and submit the PSUR:

Device Class	Minimum Frequency
Class B	Once every 2 years
Class C & D	Annually (once every year)

Content Requirements:

Results and conclusions of PMS data analysis.
Summary of any preventive and corrective actions taken.
Justification for risk-benefit conclusions remaining favorable.
Sales volume data and estimates of product usage.
Identification of any trends indicating potential safety signals.

Submission and Review:

Class C and D: The PSUR must be uploaded to EUDAMED and is reviewed by the notified body.
Class B: Must be available to the notified body on request.

Reference: Annex III Section 1(c) and Article 81, IVDR 2017/746.

Post-Market Performance Follow-up (PMPF)

The PMPF Plan is a specific subset of the PMS Plan that addresses long-term scientific and performance questions.
It is particularly important when:

Residual risks remain after risk control measures.
There is limited clinical data at launch (e.g., novel biomarkers or rare conditions).
Continuous improvements or software updates could affect performance.

The PMPF Plan should include:

Specific objectives (e.g: confirm long-term stability of a reagent, verify clinical cut-off values).
Methods such as prospective clinical follow-up, registries, user feedback programs, or post-market clinical studies.
Triggers for action if results indicate declining performance or new hazards.

The manufacturer must document results in a PMPF Evaluation Report, which feeds back into the Performance Evaluation Report (PER) and the Risk Management File.

Reference: Annex III Section 1(d) and Annex XIII Part B.

Integration with the Technical File and Quality System

Annex III requires that all PMS outputs feed back into the broader QMS:

Risk Management: New risks or trend signals must update the ISO 14971 risk file and GSPR checklist.
Performance Evaluation: Data must inform the ongoing clinical and analytical performance evaluations (Annex XIII).
Corrective Actions: Significant safety findings may trigger Field Safety Corrective Actions (FSCA) or updates to labeling and IFUs.

This closed-loop system ensures that evidence generated post-market strengthens the device’s entire technical documentation over time.

Practical Implementation Tips

Plan Early: Draft PMS and PMPF Plans during product development to ensure smooth integration.
Use Templates: Maintain consistent PMS and PSUR formats aligned with notified body expectations.
Data Analytics: Employ statistical tools for trend analysis to meet IVDR’s requirement for proactive signal detection.
Version Control: Keep a document history to prove when and how each update was made.

EUDAMED Readiness: Prepare for electronic PSUR submission and vigilance reporting as EUDAMED modules go live.

Summary Table: Annex III Deliverables by Device Class

Deliverable	Class A	Class B	Class C	Class D
PMS Plan	✔ Required	✔ Required	✔ Required	✔ Required
PMS Report	✔ Required	–	–	–
PSUR	–	Every 2 years	Every year	Every year
PMPF Plan & Evaluation	If applicable	If applicable	If applicable	If applicable

Class-Based Differences in Documentation

The depth and scrutiny of technical documentation scales with device class:

Class A (non-sterile): Self-declaration is allowed. Documentation is simpler but must still meet all GSPRs and PMS obligations.
Class B, C, D: Notified body assessment is mandatory. Expect additional requirements such as detailed clinical evidence, PMPF plans, and QMS audits.

Reference: Article 48 and Annex IX to XI of IVDR, which describe conformity assessment routes for each class.

Key Considerations for Manufacturers

Language and Format

Must be clear, organized, and searchable, ideally with a logical table of contents and cross-references.
Language: As per Article 10(14), the documentation must be in an official EU language accepted by the Member State (often English, plus the local language for IFUs and labels).

Updates and Maintenance

Technical documentation is a continuous compliance tool.
It must integrate outcomes from PMS, vigilance, and performance evaluation activities.
Significant design or manufacturing changes trigger updates and, in some cases, re-assessment.

Reference: Article 56 and Annex XIII (vigilance and PMS obligations).

Traceability and UDI

Each device must carry a Unique Device Identification (UDI), recorded consistently across the technical file, declaration of conformity, and EUDAMED.

Tips for a Compliant Technical File

Map every section explicitly to the Annex I GSPRs to show conformity at a glance.
Include verification and validation protocols and reports, not just summaries.
For software or algorithm-based IVDs, add lifecycle documentation (e.g., IEC 62304 compliance).
Include a signed Declaration of Conformity as per Annex IV.

Maintain a change log and version control system so notified bodies can easily see updates.

IVD Technical Documentation Checklist

To simplify your process, here’s a high-level checklist of essential items for your IVD technical documentation from Annex II:

Device Description & Intended Purpose

Provide a complete and precise description of the IVD device, including trade name, model, accessories, and variants. Clearly state the intended purpose (diagnosis, screening, monitoring, or prognosis), target population, user profile (professional or lay), and specimen types. This section sets the foundation for risk classification and conformity assessment.

Risk Management File (per ISO 14971)

Maintain a risk management file demonstrating the systematic identification, evaluation, control, and monitoring of risks across the device lifecycle. Include a risk analysis, risk-benefit assessment, and evidence of risk control measures. The file should be continuously updated using post-market surveillance data.

GSPR Checklist (Annex I)

Prepare a checklist mapping each General Safety and Performance Requirement to supporting evidence such as design documents, test reports, and performance data. This proves compliance with essential requirements like chemical, biological, and electrical safety, labeling, and performance reliability.

Manufacturing and Design Controls

Describe all design and manufacturing steps, from raw material sourcing to final release. Provide flow diagrams, key equipment details, process validation data, and quality control measures. This ensures reproducibility and traceability of every batch and supports CE marking.

Scientific Validity Report

Demonstrate the scientific basis for the device’s intended purpose by establishing the link between the analyte and a clinical condition or physiological state. Draw on peer-reviewed literature, established guidelines, or consensus documents, and justify the clinical relevance of the biomarker.

Analytical Performance Data

Show how accurately and reliably the device measures the intended analyte under specified conditions. Include data on accuracy, precision, sensitivity, specificity, limits of detection and quantification, and interference testing. All studies must be conducted according to recognized standards and fully documented.

Clinical Performance Report

Provide evidence that using the device leads to correct clinical decisions and beneficial outcomes. Include data from prospective or retrospective studies, literature reviews, and real-world evidence. This section confirms that analytical performance translates into actual clinical value.

Performance Evaluation Plan & Report

Under Annex XIII, document the complete performance evaluation process.

Plan (PEP): Outlines methods, data sources, and acceptance criteria for scientific validity, analytical, and clinical performance.
Report (PER): Summarizes findings, evaluates benefit-risk balance, and justifies the device’s continued use. Both must be regularly updated.

PMS Plan and PMS/PSUR Reports

Develop a Post-Market Surveillance (PMS) Plan describing how safety and performance data will be collected and analyzed once the device is on the market. Submit regular PMS reports or Periodic Safety Update Reports (PSUR)—mandatory for Class C and D devices—covering trend analysis, vigilance, and corrective actions.

Labeling, IFU & UDI Details

Provide final artwork and content for all labeling and Instructions for Use (IFU), ensuring they meet Annex I language and readability requirements. Include Unique Device Identification (UDI) details for traceability and ensure instructions cover installation, operation, maintenance, and disposal.

Summary of Safety and Performance (for Class C & D)

Prepare a concise public summary that highlights the device’s intended purpose, key safety and performance data, and clinical benefits. This must be written in clear, non-technical language and is published on EUDAMED for transparency.

Certificates and Notified Body Reports (if applicable)

Attach relevant certificates (e.g., ISO 13485, CE marking) and assessment reports from the Notified Body. These documents confirm conformity assessment completion and validate the accuracy of the technical documentation.

Conclusion

Under IVDR 2017/746, technical documentation is not merely a regulatory formality—it is the lifeline of compliance and market access. By building a structured, living file that reflects Annex II and Annex III requirements and remains up to date with PMS and vigilance data, manufacturers ensure that their IVD devices meet the EU’s highest standards for safety, performance, and traceability.

How Morulaa Healthtech Can Help

Morulaa HealthTech supports IVD manufacturers in preparing and maintaining IVDR 2017/746–compliant technical documentation.We perform gap assessments, draft or update the full technical file (Annex II & III), and create robust PMS and PMPF plans. Our team ensures clinical and analytical performance evidence, risk management alignment (ISO 14971), and smooth notified body and EUDAMED submissions.We also provide ongoing updates covering PMS reports, PSURs, and design changes so your documentation remains audit-ready and market-compliant With Morulaa, IVDR technical documentation becomes a streamlined, end-to-end compliance process.