Navigating IVDR 2017/746: How to Prepare Compliant Technical Documentation for IVD Devices
EU IVDR Technical Documentation Guide: Annex II & III Rules
Technical documentation for In Vitro Diagnostic (IVD) plays an essential role within the EU IVDR 2017/746 regulation. Documentation ensures the compliance of IVD devices in terms of safety, performance, and quality throughout the lifecycle of the product. The set of documents covers all aspects including design, production, clinical data, risk management, and post market surveillance strategy.
Annex II to IVDR obliges manufacturers to prepare technical documentation prior to putting their devices on the EU market. Technical documentation should be kept updated by the manufacturers to obtain and keep CE marking.
Technical Documentation according to IVDR
Technical documentation refers to the complete set of documents proving the conformity of the IVD in accordance with IVDR.
It includes all stages of the IVD lifecycle, including its design and purposes.
Legal Basis:
Article 10(4): states that manufacturers have the obligation to prepare technical documentation prior to the placing of the device on the market.
Article 10(9): demands that such documentation comply with the provisions set forth in Annex II and Annex III.
it is a living document that must be actively updated.
Technical Documentation Structure
IVDR separates technical documentation into two major sections.
Annex II – Technical Documentation (Core File) from Annex II (Sections 1-6), 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) contains the technical Documentation on post market requirements to complement design and pre market information in Annex II. Whereas Annex II demonstrates initial compliance, Annex III will make sure that the IVD satisfies the GSPRs in its entire life cycle. It is important as usage in the real world may uncover some risks, performance patterns, and/or problems with users which may not have become apparent during the pre market evaluation.
In accordance with Article 10(9), manufacturers shall develop and update PMS documentation as laid down in Annex III to include in the complete technical documentation of the IVD.
PMS Plan - The Key Road Map
The PMS plan is the key road map to the continuous monitoring of the IVD after being put on the market.
It should be tailored to the IVD and proportional to the risk class and intended use of the IVD.
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 Part 1(a), IVDR 2017/746.
PMS Report for Class A IVD Devices
For Class A non sterile IVD devices, IVDR permits a simple PMS Report output.
Content: Summary of PMS activities, important findings, complaints, CAPA actions, and trends.
Frequency: This report must be available on request from competent authorities.
Purpose: To show that even low risk IVD devices are safe and function 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 mandatory as per the IVDR of the EU.
It is applicable to the higher risk class of IVDs i.e. Class B, C, and D.
The PSUR is a more detailed and comprehensive document than the standard Post Market Surveillance (PMS) report.
Submission Frequency:
The frequency of submission is mentioned in the table below:
Device Class | Minimum Frequency |
|---|---|
Class B | Once every 2 years |
Class C & D | Annually (once every year) |
Content Requirements:
Results and conclusions from the analysis of PMS data.
Summary of any preventative and corrective action measures taken.
Reason for favorable risk benefit conclusions.
Information about the sales volume and use of the product.
Identification of any trends suggesting safety concerns.
Submission and Review:
Class C and D: The PSUR should be submitted to the EUDAMED portal and will be reviewed by the notified body.
Class B: Shall be made available to the notified body upon request.
References: Annex III Section 1(c) and Article 81, IVDR 2017/746.
Follow up Post Market Performance (PMPF)
PMPF Plan is a particular part of the PMS Plan addressing scientific and performance concerns in the long run. It is especially necessary when:
Residual risks persist despite risk control measures.
Clinical information is limited at the time of launch (novel biomarkers, rare diseases, etc.).
Further development/improvements may impact performance.
PMPF Plan includes the following:
Objective (e.g.: to assess long term stability of a reagent, clinical cut off values).
Activities including prospective follow ups, registries, feedback from users, or post market clinical studies.
Deciding criteria when the findings demonstrate deteriorating performance or emerging hazards.
The results of the manufacturer shall be included in the PMPF Evaluation Report that will then contribute to the Performance Evaluation Report (PER) and Risk Management File.
Ref.: Annex III Section 1(d) and Annex XIII Part B.
Integration within the Technical File and Quality System
Annex III mandates that all PMS outputs be integrated into the wider quality management system:
Risk Management: Any new risks or trends have to update the ISO 14971 risk management file and GSPR checklist.
Performance Evaluation: Information has to update the continuous performance evaluation studies (Annex XIII).
Corrective Actions: Any new safety information may result in Field Safety Corrective Action (FSCA) or labeling/IFU update.
The feedback loop helps ensure that any data collected post market improves the entire technical documentation of the medical device.
Suggestions for Practical Implementation
Planning Ahead: Draw up plans of PMS and PMPF while developing the product to facilitate its seamless integration.
Templates: Stick to templates of PMS and PSUR that follow the requirements of the notified body.
Data Analysis: Use statistics in trend analysis in order to fulfill the IVDR requirements concerning signal detection in advance.
Document History: Document all changes in order to track them back.
Preparation for EUDAMED: Get ready for electronic submission of PSUR and vigilance reporting as EUDAMED modules become operational.
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 |
Differences between Documentation for Different Classes
The level of documentation and analysis increases according to the class of the device:
Class A (not sterile): Self declaration is permitted. The documentation is less complex but still has to comply with all GSPRs and PMS responsibilities.
Classes B, C, D: Assessment by notified body is necessary. Some further requirements may be expected, including clinical evidence, PMPF plan, QMS audit.
Refer: Article 48 and Annexes IX to XI of IVDR.
Key Points for Manufacturers
Language and Layout
Needs to be clear, well organized, and searchable, ideally including a proper table of contents and cross references.
Language: In accordance with Article 10(14), the documents should be in one of the languages officially recognized by the EU Member States (usually English and the national language for IFUs and labels).
Updates and Maintenance
Technical documentation is an ongoing means of compliance.
It needs to be based on the results of vigilance and performance evaluation processes.
Changes in design or manufacturing processes result in updates and sometimes re-evaluation.
Reference: Article 56 and Annex XIII (vigilance and PMS).
UDI and Traceability
Each device shall be assigned a Unique Device Identification (UDI) consistently throughout the technical file, declaration of conformity, and EUDAMED.
Tips for a Compliant Technical File
Link each item in the technical file to Annex I GSPRs.
Verification and validation protocols and reports should be included in the technical file; not summary pages only.
For algorithm/software IVDs, include life cycle management evidence (such as IEC 62304).
Signed Declaration of Conformity from Annex IV.
Keep track of changes in a version controlled change log.
Checklist for IVD Technical Documentation
Here is a high level list of things that will make your IVD technical documentation from Annex II more organized:
Description of the Device & Its Intended Purpose
Give a detailed description of the IVD device, mentioning its trade name, model, accessories, and different variants. Explain the purpose of the IVD (diagnosis, screening, monitoring or prognosis), the target population, user profile (professional or lay) and specimens involved. Here you set up the ground for risk class determination and conformity assessment.
Risk Management File (according to ISO 14971)
Maintain a risk management file to show that the systematic risk identification, evaluation, control and monitoring is done throughout the device lifecycle. It should contain information about risk analysis, risk benefit assessment and proof that there are measures of risk control in place. The risk management file should be constantly updated based on post market surveillance data.
GSPR Checklist (from Annex I)
Create a checklist that matches each General Safety and Performance Requirement with the corresponding evidence – design files, test reports, performance data. You demonstrate compliance with general requirements on chemical, biological and electrical safety, labeling and performance.
Manufacturing and Design Controls
Describe every stage of design and manufacturing of the device starting with procurement of raw materials and ending with final release. Provide information about flow diagrams, main equipment used, process validation, quality control.
Scientific Validity Report
Show the scientific rationale behind the intended purpose of your IVD device by describing the link between the analyte and a clinical condition or physiological state. Base the report on the peer reviewed literature, guidelines or consensus documents and give an explanation of clinical relevance of the biomarker.
Analytical Performance Data
Provide information that demonstrates analytical performance of the device. It includes data on accuracy, precision, sensitivity, specificity, limits of detection and quantification and interference studies. All studies should be done according to recognized standards and described in detail.
Clinical Performance Report
Present data proving that using the device results in proper clinical decision making and positive outcome. You should provide data from prospective or retrospective studies, literature review or other sources of real world evidence.
Performance Evaluation Plan & Report
As per Annex XIII, describe the entire process for the evaluation of performance.
Performance Evaluation Plan (PEP): Details approaches used, sources of information, and acceptance criteria for scientific validity, analytical and clinical performance.
Performance Evaluation Report (PER): Describes results, assesses risk benefit relationship, and explains the continued use of the device.
PMS Plan and PMS/PSUR reports
Create a Post Market Surveillance (PMS) plan which will describe methods of safety and performance data collection and analysis after the device goes to the market. Provide PMS reports or Periodic Safety Update Reports (PSURs) required for Class C and D discussing trend analysis, vigilance, and corrective action.
Labeling, IFU & UDI Information
Provide final artwork and content of all labels and Instructions for Use (IFUs). They should be prepared according to the requirements for Annex I, as well as include UDI information, instructions for the installation, operation, maintenance and disposal.
Summary of Safety and Performance (for Class C & D)
Prepare a short public summary of the device including information about its intended purpose, safety and performance data, as well as clinical benefits of using the device. This document should be easily understandable and written in non technical language; it will be published on EUDAMED.
Certificates and Notified Body Reports (if applicable)
Provide related certificates (for example ISO 13485, CE marking) and reports of assessment by the Notified Body which will prove completion of the conformity assessment procedure and accuracy of the technical documentation.
Conclusion
According to the IVDR 2017/746, technical documentation is not only a regulatory requirement; it is a tool of market access. By preparing the structured and constantly updated technical file which is compliant with Annex II and Annex III of the Regulation, IVD manufacturers make sure that their medical devices comply with the high standards of safety, performance and traceability.
How Morulaa HealthTech Can Help
Morulaa HealthTech assists IVD manufacturers in preparing and updating technical documentation under the IVDR 2017/746 We carry out gap assessment and prepare or update the complete technical file (Annex II & III); we develop strong PMS and PMPF plans.
We guarantee that our clients have evidence of clinical and analytical performance, risk management procedures are aligned with ISO 14971, and submission to Notified Body and EUDAMED goes smoothly.
Moreover, we provide ongoing updates in the form of PMS reports, PSURs, and design changes in order to keep your technical documentation up to date.
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