IVDR Technical Documentation: Requirements and Submission Process

IVDR technical documentation (technical file) is the structured set of evidence required under Regulation (EU) 2017/746 to demonstrate that an in vitro diagnostic (IVD) device complies with applicable safety, performance, and lifecycle requirements. An IVDR technical file is needed to support conformity assessment, Notified Body review (where applicable), CE marking, and ongoing post-market compliance. A technical file is needed by legal manufacturers of IVDs and organizations acting on their behalf for regulatory compliance activities.

Key technical documentation requirements under IVDR are listed below.

• Device Description and Specification: Defines the IVD’s identity, intended purpose, configuration, specimen type, and operating principles to establish the scope of the technical documentation and support classification, performance evaluation, risk management, and traceability.
• Classification Rationale and Conformity Assessment Route: Documents the device classification per Annex VIII and justifies the applicable conformity assessment route under Annex IX, X, or XI, determining the level of Notified Body involvement.
• Design and Manufacturing Information: Documents design realization and manufacturing processes, including materials, critical process parameters, production controls, and process validation, to ensure consistent device quality and performance.
• General Safety and Performance Requirements (GSPR) Checklist: Provides a structured cross-reference demonstrating conformity with all applicable Annex I requirements by linking each GSPR to objective supporting evidence.
• Risk Management Documentation: Demonstrates systematic identification, assessment, and control of risks throughout the device lifecycle, including risks related to incorrect results, with justification of residual risk acceptability.
• Performance Evaluation Evidence (Annex XIII): Establishes scientific validity, analytical performance, and clinical performance in line with the intended purpose, supported by documented study data maintained as a lifecycle activity.
• Verification and Validation Data: Confirms that design outputs meet design inputs and the device meets user needs and intended use through analytical and clinical performance studies, system integration testing, stability studies, and software verification and validation, where applicable.
• Labeling and Instructions for Use (IFU): Ensure labels and IFUs comply with Annex I, Chapter III, and accurately reflect intended use, performance claims, limitations, and residual risks.
• UDI and Traceability Documentation: Documents the implementation of the UDI system in accordance with Annex VI, including Basic UDI-DI assignment, to enable traceability across certification, PMS, and vigilance activities.
• Post-market Surveillance (PMS) and PMPF Documentation: Describes the systematic, risk-based plans and processes used to monitor post-market performance in accordance with Annex III and Annex XIII, including feedback into risk management and performance evaluation.

The IVDR technical file submission process involves preparing complete Annex II and Annex III files, selecting the applicable conformity assessment route (Annex IX, X, or XI), and, where required, submitting the documentation to a designated Notified Body. Notified Bodies expect clearly indexed, searchable electronic files, consistent structure, and explicit cross-references between claims, evidence, and conclusions.

During review, Notified Bodies assess completeness, internal consistency, and adequacy of evidence, focusing on performance evaluation, risk management, GSPR conformity, labeling alignment, and PMS/PMPF readiness. Common expectations of notified bodies include structured file hierarchies (PDF-based submissions), traceable GSPR matrices, and well-referenced performance study reports.

Organizations preparing IVDR technical documentation can rely on regulatory experts, Notified Body–aligned templates, IVDR checklists, MDCG guidance documents, and pre-submission gap assessments. These resources help interpret regulatory requirements, structure documentation correctly, identify gaps early, and reduce questions and review cycles from Notified Bodies.

SimplerQMS supports IVDR technical documentation by providing a controlled eQMS environment for creating, maintaining, and updating Annex II and Annex III documentation. The platform enables document control, requirements-to-evidence traceability, change management, and linkage between risk management, performance evaluation, and PMS activities, helping organizations maintain IVDR-compliant Technical Documentation throughout the device lifecycle.

What Is IVDR Technical Documentation?

IVDR technical documentation is the complete, controlled set of records that demonstrates an in vitro diagnostic (IVD) device’s conformity with Regulation (EU) 2017/746 throughout its lifecycle (IVDR). IVDR technical documentation is the formal evidence used to support conformity assessment, CE marking, and ongoing regulatory compliance under the IVDR.

Under Regulation (EU) 2017/746, technical documentation is defined in Annex II Technical Documentation and Annex III Technical Documentation on Post-Market Surveillance. Annex II and Annex III document how the IVD device meets the general safety and performance requirements (GSPRs) in Annex I, as well as applicable performance, risk, and post-market requirements.

The primary purpose of IVDR technical documentation is to provide objective, traceable evidence that the IVD device is safe, performs as intended, and complies with all applicable regulatory requirements before and after it is placed on the EU market. IVDR technical documentation forms the basis for Notified Body review, regulatory inspections, and continued market access.

The legal manufacturer is responsible for preparing, maintaining, and keeping the technical documentation up to date. Authorized Representatives must have access to the documentation upon request, and manufacturers remain accountable for its completeness, accuracy, and availability throughout the device lifecycle.

IVDR technical documentation includes information covering device description, intended purpose, classification, design and manufacturing processes, risk management, GSPR conformity, verification and validation, performance evaluation, labeling, and post-market surveillance. IVDR technical documentation must be maintained as a living file and updated in response to design changes, post-market data, or regulatory feedback, to name a few.

All IVD devices placed on the EU market require IVDR technical documentation, regardless of risk class. The depth and extent of documentation depend on the IVD’s risk classification (Class A, B, C, or D), with higher-risk devices subject to increased scrutiny and mandatory Notified Body involvement.

How Does Device Classification under IVDR Influence Technical Documentation Requirements?

Under the IVDR, device classification determines the scope and the level of detail of technical documentation, as well as the applicable conformity assessment pathway. As the risk class increases, the regulation requires more extensive performance evidence, stronger post-market controls, and greater Notified Body involvement.

As per EU IVDR medical device classification, IVD devices are classified as Class A, B, C, or D in accordance with IVDR Annex VIII, based on intended purpose and the potential risk to individuals and public health. The classification directly affects the content of Annex II–III Technical Documentation and the applicable conformity assessment procedure under Annexes IX, X, or XI.

The different IVD device risk classes under IVDR are listed below.

• Class A (Low Risk): IVD Class A technical documentation must fully address Annex II and Annex III requirements, including device description, GSPR conformity, risk management, verification activities, labeling, and PMS. Performance evaluation and post-market activities are limited to what is necessary to demonstrate basic safety and functionality, and conformity assessment is typically based on manufacturer self-certification, with Notified Body involvement only for sterile Class A devices.
• Class B (Moderate Individual Risk): IVD Class B technical documentation must include complete Annex II and Annex III content supported by documented analytical performance studies, defined acceptance criteria, and a structured PMS system. The documentation is subject to Notified Body review to verify that performance claims, risk controls, and post-market surveillance activities are adequately justified and consistently implemented.
• Class C (High Individual Risk or Moderate Public Health Risk): IVD Class C technical documentation must provide a more comprehensive performance evaluation covering scientific validity, analytical performance, and clinical performance, alongside detailed risk management and post-market performance follow-up (PMPF) planning per Annex III. The primary purpose is to determine whether the IVD remains safe and effective or if any new or unanticipated risks have emerged since market placement. The Full Notified Body assessment applies, with an increased focus on benefit–risk justification and lifecycle controls.
• Class D (High Individual and Public Health Risk): IVD Class D technical documentation must additionally support batch-related controls and, where applicable, EU Reference Laboratory involvement, reflecting the highest level of independent verification required under IVDR. Conformity assessment includes the most stringent scrutiny by a Notified Body and may involve batch verification or external laboratory review due to the significant public health impact of potential device failures.

What Are the Core Requirements for IVDR Technical Documentation?

IVDR technical documentation must demonstrate that an in vitro diagnostic device complies with Regulation (EU) 2017/746 across its entire lifecycle. The core requirements are defined primarily in Annex II (Technical Documentation) and Annex III (Technical Documentation on Post-Market Surveillance), with additional obligations linked to Annex I (GSPRs) and Annex XIII (Performance Evaluation). The documentation must be complete, traceable, and proportionate to the device’s risk class.

The core requirements for technical documentation under the EU IVDR are listed below. 

1. Device Description and Specification: Device description and specification describe the IVD device, including its intended purpose, risk classification, components, accessories, variants, and principles of operation, enabling clear device identification and regulatory traceability.
2. Reference to Previous and Similar Devices: Reference to previous and similar devices documents prior generations or equivalent devices, where applicable, to support the current device’s design rationale, performance claims, and continuity of technical evidence.
3. Performance Evaluation: Performance evaluation encompasses analytical and clinical performance characteristics, including claimed performance parameters, limits, and acceptance criteria relevant to the IVD’s intended purpose.
4. Design and Manufacturing Information: Design and manufacturing information describes design processes, manufacturing methods, materials, and production controls applied to ensure consistent and controlled IVD device realization.
5. General Safety and Performance Requirements (GSPR) Checklist: The GSPR checklist provides a structured cross-reference demonstrating conformity with all applicable Annex I GSPRs by linking each requirement to objective supporting evidence. For example, a GSPR requirement related to analytical performance is linked to the relevant analytical performance study report, the associated risk control measures addressing potential incorrect results, and the corresponding performance claim in the IFU.
6. Risk Management (Annex I + ISO 14971): The risk management process demonstrates identification, evaluation, control, and monitoring of risks and confirmation of residual risk acceptability in relation to intended benefits.
7. Product Verification and Validation: Product verification and validation demonstrate that design outputs conform to defined design inputs and that the device meets user needs and intended use requirements. For IVDs, this includes analytical performance studies and system-level testing that confirm the device performs as intended under representative conditions of use.
8. Stability and Packaging Validation: Stability and packaging validation provide objective evidence that the device maintains its performance characteristics throughout its claimed shelf life and under defined transport, storage, and in-use conditions. This validation supports labeling claims and demonstrates that the packaging adequately protects the device and does not adversely affect device performance.
9. Labeling and Instructions for Use (IFU): Labeling and IFU document the information provided to users to enable correct device use, result interpretation, and risk mitigation in accordance with Annex I, Chapter III. This includes warnings, limitations, and instructions necessary to ensure safe and effective use of the IVD.
10. UDI System and Traceability: The UDI system and traceability section documents the assignment and implementation of the UDI system in accordance with Articles 24–25 and Annex VI. UDI enables unambiguous device identification and supports traceability across distribution, field safety actions, and post-market surveillance.
11. Post-Market Surveillance (PMS): Post-market surveillance describes the systematic, risk-based process used to proactively collect, analyze, and evaluate post-market information to confirm ongoing safety and performance. PMS documentation demonstrates compliance with Annex III requirements and supports lifecycle risk management.
12. Post-Market Performance Follow-Up (PMPF): Post-market performance follow-up defines activities conducted to proactively collect and evaluate performance data during routine clinical use. PMPF forms part of the performance evaluation lifecycle and is used to confirm scientific validity and device performance, while addressing residual uncertainties identified during pre-market assessment.
13. Summary of Safety and Performance (SSP): Summary of safety and performance provides a publicly accessible overview of key safety and performance information for high-risk IVDs such as Class C and Class D IVDs. The SSP ensures transparency and consistency between publicly available information and the approved technical documentation.
14. Metrological and Software Information: Metrological and software information documents measurement traceability, calibration, and software lifecycle controls where these elements affect device performance or result interpretation. This information supports the reliability, accuracy, and reproducibility of IVD results in line with Annex I requirements.

1. Device Description and Specification

Device description and specification establish the regulatory identity and scope of the IVD device in accordance with IVDR Annex II, Section 1.1. This section defines the boundaries of the conformity assessment by clearly explaining how the device functions, what it measures, and under which conditions it is intended to be used.

A compliant IVDR submission will describe the complete system configuration, including instruments, reagents, calibrators, controls, accessories, and software components, and explain how these interact to generate results. Notified Bodies expect explicit alignment between the described configuration and downstream analytical and clinical performance studies, for example, by referencing which reagent lots, analyzer versions, and specimen matrices were used in validation.

Device description and specification documentation are prepared and maintained by the legal manufacturer and include a reference to the applicable IVDR classification. It is typically documented as controlled device descriptions, intended purpose statements, configuration matrices, and system diagrams that clearly describe the device components, variants, and operating principles.

The information is typically placed in a section of the technical file called device identification and system configuration. The information in the device description section is cross-referenced to performance evaluation evidence, risk management assumptions, labeling claims, and UDI records to ensure consistency and traceability across the file.

2. Reference to Previous and Similar Devices

The reference to the previous and similar devices section supports design justification and continuity of technical evidence under Annex II, Section 1.2, where applicable. This section is critical when manufacturers rely on platform technology, prior device generations, or incremental design changes to support performance evaluation or risk management.

Notified Bodies expect a clear explanation of what data is reused, what is new, and what has changed, including limitations of equivalence. For example, if analytical performance data from a predecessor assay is referenced, the documentation must justify that differences in reagents, intended purpose, specimen type, or software, etc., do not invalidate the applicability of those results to the device under assessment.

Documentation relating to previous and similar devices is maintained by the legal manufacturer as controlled equivalence and lineage justification records. Comparative tables typically identify the predecessor or similar device and systematically compare key elements such as intended purpose, design and operating principles, reagents or materials, specimen type, software, performance characteristics, and risk profile against the current device.

Supporting rationales explain whether differences impact safety or performance and are substantiated, where necessary, by updated analytical or clinical performance data, revised risk management documentation, and documented design changes, demonstrating that any new or changed risks are adequately addressed.

3. Performance Evaluation

Performance evaluation defines the measurable claims of the IVD device and forms the baseline against which verification, validation, and post-market performance are assessed. Requirements for performance evaluation are specified in Annex XIII of the IVDR. The purpose of performance evaluation is to ensure that the IVD’s intended purpose and claims are sufficiently translated into concrete and verifiable performance endpoints.

Specifications such as diagnostic sensitivity and specificity, measuring range, precision, among others, must be clearly stated and justified in Performance Evaluation Plans and Reports. Each specification must be traceable to analytical and clinical performance study outputs, with acceptance criteria that reflect clinical relevance and risk considerations.

Performance evaluation documentation is prepared and maintained by the legal manufacturer as controlled performance evaluation plans (PEP) and performance evaluation reports (PER), and supporting test reports. Performance validation documentation includes scientific validity, analytical performance, and clinical performance. It is included in the verification and validation section of the technical documentation, where performance claims are defined and substantiated, with direct linkage to study datasets, acceptance criteria, and IFU claims.

Notified Bodies expect specification tables that explicitly reference the study reports and datasets used to confirm each claim. These specifications must align with labeling claims and IFU instructions to avoid inconsistencies during review.

4. Design and Manufacturing Information

Design and manufacturing information demonstrates that the IVD is consistently designed and produced in accordance with Annex II, Section 3. This section must provide sufficient transparency for a Notified Body to understand how design decisions and manufacturing controls influence device performance and result reliability.

Technical documentation must describe critical design characteristics, material selections, system overviews, and manufacturing process parameters that influence device performance. Design controls are demonstrated through documented design and development activities, including design planning, input/output specifications, verification and validation, reviews, and change control. Validation evidence for manufacturing processes includes documented process validation studies, lot-to-lot consistency data, reagent formulation validation, lot release acceptance criteria, and environmental control qualification results, demonstrating the consistent production of devices meeting defined performance specifications and GSPR requirements.

Design and manufacturing documentation are prepared and maintained by the legal manufacturer under the QMS. Design and manufacturing information are typically presented as design specifications, manufacturing flow descriptions, process validation summaries, and supplier control records.

Design and manufacturing information is placed in the technical documentation, where design realization and production controls are described, with cross-references to product verification and validation reports, risk management documentation, labeling, and PMS evidence.

5. General Safety and Performance Requirements (GSPR) Checklist

The GSPR checklist is the central compliance map required by Annex II, Section 4, demonstrating conformity with Annex I. The GSPR checklist is one of the primary tools used by Notified Bodies to navigate the technical documentation during assessment.

Each applicable GSPR must be explicitly addressed, with justification for applicability or non-applicability and direct references to supporting evidence. For example, requirements related to performance must reference analytical and clinical performance studies, while requirements related to risk control must reference the risk management file and verification of implemented controls. Checklists must avoid generic references and instead provide precise document names, sections, and evidence locations, enabling efficient and transparent review.

The GSPR checklist is maintained by the legal manufacturer as part of regulatory compliance documentation. A GSPR checklist is typically structured as a controlled clause-by-clause cross-reference matrix in the technical documentation linking each Annex I requirement to specific documentation in the technical file across design, risk, performance evaluation, labeling, and post-market surveillance sections.

6. Risk Management (Annex I + ISO 14971)

Risk management demonstrates conformity with the general safety and performance requirements by documenting how risks associated with the IVD are systematically identified, evaluated, controlled, and reviewed throughout the device lifecycle. For IVDs, this documentation must explicitly address risks related to incorrect results (e.g., false positives or false negatives), foreseeable misuse, specimen handling errors, result interpretation by the user, and other hazards that could affect device performance or safety. Risk management activities are performed and documented per ISO 14971 requirements.

In line with ISO 14971 requirements, the risk management file must demonstrate direct traceability between identified hazards and the analytical or clinical performance evidence used to mitigate those risks. For example, the risk of false-negative results must be supported by analytical sensitivity and clinical performance data, while risks from interfering substances must be supported by analytical specificity and interference studies. The file must also show how post-market surveillance and PMPF data are periodically reviewed and incorporated to update risk evaluations, labeling warnings, and benefit–risk conclusions over time.

The risk management file is maintained by the legal manufacturer as a controlled ISO 14971-aligned risk management file. A risk management file is typically structured to document risk management planning, hazard identification, risk assessment, risk control implementation, residual risk evaluation, and benefit–risk justification and is placed within the technical documentation under a dedicated Risk Management section. The risk management file must have traceability to performance evidence, labeling warnings, post-market surveillance outputs, and other relevant sections of the technical documentation.

7. Product Verification and Validation

Product verification and validation provide the core technical evidence required under Annex II, Section 6, to demonstrate that the IVD meets its intended use and defined performance specifications. For IVDs, this includes analytical performance verification and validation, system validation, and clinical performance studies conducted using representative specimens from the intended use population.

Design verification confirms that design outputs meet design input requirements through documented testing of analytical performance parameters. Design validation confirms the device meets user needs and intended use through clinical performance studies. IVD clinical performance validation relies on diagnostic performance against reference methods. Validation studies must be clearly designed to support the intended purpose, specimen type, and user population. Notified Bodies expect structured validation summaries that clearly link study design, acceptance criteria, results, and conclusions to performance claims and GSPR compliance.

Product verification and validation documentation is maintained by the legal manufacturer. Product verification and validation documentation is typically presented as controlled verification and validation protocols, test reports, and validation summaries. It is placed in the Verification and Validation section of the technical documentation, together with supporting performance evaluation plans, reports, and related test evidence.

8. Stability and Packaging Validation

Stability and packaging validation support shelf-life, storage, and transport claims under Annex II, Section 6, and are particularly critical for reagent-based IVDs. The stability and packaging validation section must demonstrate that analytical performance remains within specification throughout the claimed shelf life and under defined transport, storage, and in-use conditions.

Stability studies should be designed to assess worst-case and stressed conditions, where appropriate, and results must be linked to performance specifications such as precision, sensitivity, or calibration stability. Packaging validation must show that packaging systems adequately protect the device during transport, storage, and handling. Supporting evidence includes stability study protocols and reports, transport simulation or packaging validation outputs, cross-referenced to labeling claims and IFU storage instructions.

Stability and packaging validation documentation are maintained by the legal manufacturer. Stability and packaging validation documentation are typically included within the verification and validation section of the technical documentation, supporting shelf-life, storage, and transport claims reflected in labeling and the IFU.

9. Labeling and Instructions for Use (IFU)

The requirements for labeling and IFU are outlined in Annex I, Chapter III. This section ensures that users receive clear, accurate, and complete information for correct device use and result interpretation.

Notified Bodies closely assess consistency between labeling claims, IFU instructions, performance evidence, and residual risks identified in the risk management file. Performance claims, limitations, warnings, and interpretation guidance must be directly supported by analytical and clinical performance data. Evidence consists of controlled final labeling and IFU artwork, including language versions, cross-referenced to performance evaluation and risk documentation.

Labeling and IFU information are prepared and maintained by the legal manufacturer and are included in the ‘Information to be Supplied by the Manufacturer’ section of the technical documentation, where user information and claims are documented.

10. UDI System and Traceability

The UDI system and traceability section document how the device is uniquely identified and traceable throughout its lifecycle. Notified Bodies expect clear and consistent traceability between UDI records, labeling, EUDAMED registrations, and post-market documentation, enabling effective field safety actions, vigilance reporting, and lifecycle oversight. Supporting evidence typically includes UDI assignment records, references within the declaration of conformity, labeling showing UDI carriers, and registration documentation maintained by the legal manufacturer.

The UDI system documentation is prepared and maintained by the legal manufacturer and is included in the technical documentation primarily within the device description and information to be supplied by the manufacturer sections.

11. Post-Market Surveillance (PMS)

Post-market surveillance (PMS) requirements are outlined in Annex III of the IVDR. The PMS section describes how post-market data is systematically collected and evaluated to confirm ongoing IVD safety and performance. PMS activities must be proportional to device risk class and capable of identifying trends, emerging risks, or performance issues.

An effective PMS system clearly links data sources such as complaints, customer feedback, and vigilance reports to defined analysis methods and escalation criteria such as CAPA initiation or risk file updates. Outputs must feed back into risk management, performance evaluation, labeling, and design updates where applicable. Evidence includes PMS plans, periodic reports, and documented trend analyses.

For Class C and Class D devices, the PMS system includes the preparation of the periodic safety update Report (PSUR), which provides a structured, periodically updated summary of post-market findings, including complaints, vigilance data, trend analyses, and relevant PMPF results. The purpose of the PSUR is to confirm continued safety, performance, and benefit–risk acceptability in accordance with Article 81.

For Class A and Class B devices, a PMS report is considered sufficient, summarizing PMS data and conclusions in proportion to the device’s risk.

PMS documentation is prepared and maintained by the legal manufacturer. It is included under a dedicated section called Post-Market Surveillance in Technical Documentation.

12. Post-Market Performance Follow-Up (PMPF)

PMPF fulfills Annex XIII, Part B requirements by extending performance evaluation into real-world use through planned, risk-based PMPF activities. PMPF documentation must define the process for collecting and analyzing post-market performance data and address residual uncertainties from pre-market performance evaluations, such as limited study populations or untested use conditions. These activities confirm the continued safety, performance, and scientific validity of the device. Evidence consists of PMPF plans and reports linked to updated performance evaluation conclusions and device benefit-risk assessments.

PMPF documentation is maintained by the legal manufacturer and is typically structured as defined post-market study plans and outcome summaries. PMPF documentation is included within the post-market surveillance section in the technical documentation.

13. Summary of Safety and Performance (SSP)

The summary of safety and performance (SSP) is required for Class C and Class D IVD devices, excluding devices for performance studies, in accordance with IVDR Article 29. SSP provides a publicly accessible summary of key safety and performance information written in clear language for intended users and patients, where relevant.

The SSP must be included in the technical documentation submitted to the Notified Body for conformity assessment, validated by the Notified Body, and made publicly available via EUDAMED, with a reference in the label or IFU indicating where it can be accessed. Core content includes device and manufacturer identification, including Basic UDI-DI and the single registration number (SRN) where available, intended purpose and target population, device description and variants, applied harmonized standards or common specifications, a summary of performance evaluation and PMPF, metrological traceability, user training profile, and information on residual risks, warnings, and precautions.

The manufacturer is responsible for preparing and maintaining the SSP, while the Notified Body validates it prior to publication, ensuring consistency with the approved IVDR technical documentation.

14. Metrological and Software Information (Where Applicable)

Metrological and software information address relevant requirements of Annex I, Chapter II, and Annex II, Section 6, where measurement functions or software influence IVD results. This section must demonstrate that software used for result generation, processing, or interpretation is designed, developed, validated, and maintained under controlled lifecycle processes, and that measurement results are accurate, reliable, and traceable.

Documentation to support metrological and software information must show how software functionality and algorithms support claimed analytical performance and how metrological traceability of assigned values or calibration references is ensured. Evidence typically includes software architecture and lifecycle documentation, software verification and validation reports, cybersecurity and data integrity considerations where relevant, and calibration or traceability records cross-referenced to analytical performance and system validation studies.

Metrological and software information documentation are maintained by the legal manufacturer as controlled software lifecycle documentation, software verification and validation evidence, and metrological traceability records. It is included within the product verification and validation section in the technical documentation.

How Does the IVDR Technical Documentation Submission Process Work?

Under the IVDR, the technical documentation submission process is the conformity assessment pathway through which a manufacturer demonstrates compliance with Regulation (EU) 2017/746 before CE marking and throughout the device lifecycle. For most Class B, C, and D IVDs, a Notified Body assesses the manufacturer’s Annex II (Technical Documentation) and Annex III (PMS Technical Documentation) as part of the applicable conformity assessment route (Annex IX, X, or XI) and issues certification when conformity is demonstrated.

For Class A IVDs (excluding sterile Class A devices), Notified Body involvement is not required, and the manufacturer self-declares conformity by compiling and maintaining compliant Annex II and Annex III technical documentation under its quality management system prior to CE marking.

The different phases of the IVDR technical documentation submission process are listed below.

1. IVDR Technical Documentation (Annex II + Annex III) Preparation: The legal manufacturer of the IVD compiles a complete Annex II and Annex III file with clear traceability between the intended purpose, classification (Annex VIII), Annex I GSPR checklist, risk management, performance evaluation (Annex XIII), labeling, and post-market surveillance plans. The file is structured so that each claim in the IFU and each GSPR line item links to specific objective evidence, such as analytical performance reports, clinical performance evidence, and PMS outputs.
2. Conformity Assessment Route Selection and Certification Scope: The legal manufacturer of the IVD determines the applicable conformity assessment route under Annex IX, Annex X, or Annex XI based on the IVDR classification and intended purpose of the device. This step defines the certification scope, including the device or device family covered, the Basic UDI-DI, and the extent of technical documentation and QMS assessment required, and includes aligning the submission structure and supporting QMS evidence with the Notified Body’s designated scope and procedural expectations.
3. Notified Body Submission: The manufacturer submits a formal application to the designated Notified Body under the selected conformity assessment route, including the complete Annex II and Annex III Technical Documentation and the required QMS documentation. The submission must demonstrate internal consistency across all modules, ensuring that the device description, performance claims, risk controls, labeling, and PMS arrangements are aligned, mutually supportive, and that the information does not conflict across modules or sections.
4. Notified Body Completeness and Admissibility Check: The Notified Body performs an initial screening to confirm the submission contains all required Annex II and Annex III elements and is within the NB’s designation scope. Typical completeness gaps include missing performance evaluation structure (scientific validity, analytical performance, clinical performance), incomplete GSPR mapping with required evidence, or PMS documentation not aligned to Annex III requirements.
5. In-depth Technical Documentation Assessment (Annex II): The Notified Body assesses Annex II content for adequacy and internal consistency, focusing on device description, classification rationale, GSPR checklist, risk management, verification and validation, performance evaluation evidence, and labeling/IFU. The NB checks that performance claims are supported by study outputs, acceptance criteria match specifications, and risk controls are verified and reflected in labeling.
6. In-depth PMS Assessment (Annex III): The Notified Body assesses Annex III content to confirm the PMS system is defined, proportionate to risk class, and capable of detecting safety or performance signals. The NB expects clear linkage between PMS data sources (complaints, vigilance, trend reporting) and lifecycle updates to risk management and performance evaluation, including PMPF where required.
7. Questions, Findings, and Iterative Review Cycles: The Notified Body issues formal questions or nonconformities when evidence is unclear, insufficient, or inconsistent across modules. The manufacturer responds by updating specific sections, submitting revised evidence (e.g., clarified performance study rationale, corrected IFU claims, updated GSPR references), and documenting corrective actions where systemic gaps are identified.
8. Conformity Assessment Conclusion and Certification Decision: Once all findings are addressed, the Notified Body finalizes the assessment conclusion against the selected route and defined scope. If conformity is demonstrated, the NB proceeds to certification; if not, the manufacturer must address outstanding deficiencies before certification can be granted.
9. Issuance of IVDR Certificates: The Notified Body issues the applicable IVDR certificate(s), typically including an EU technical documentation assessment certificate and, where applicable, an EU QMS certificate aligned to the conformity assessment route. Certificates are scope-bound and subject to surveillance and renewal requirements, with continued compliance dependent on maintaining current Annex II and III documentation.
10. Registration and Market Placement Activities (EUDAMED, where applicable): The manufacturer completes required registrations, including Basic UDI-DI and device registration in EUDAMED when the relevant modules are available and applicable. The manufacturer then affixes the CE marking and places the device on the EU market only within the certified scope and approved labeling.
11. Ongoing Obligations After Approval (lifecycle maintenance): After certification, the manufacturer must keep Annex II and Annex III documentation current through change control, PMS, and PMPF execution, vigilance reporting, and periodic review of performance evaluation conclusions. Significant changes, emerging risk via PMS data, or revised risk conclusions must trigger controlled documentation updates and may require NB notification or reassessment depending on the change impact and the conformity assessment route.

How Do Notified Bodies Review Annex II and Annex III Documents?

Under the IVDR, a Notified Body (NB) review verifies that the manufacturer’s technical documentation in Annex II and Annex III provides complete, consistent, and objective evidence of conformity with Regulation (EU) 2017/746. The review confirms that safety, performance, and post-market obligations are adequately demonstrated and supported by an implemented and effective quality management system.

Notified Bodies evaluate technical documentation against IVDR legal requirements, applicable harmonized standards, common specifications, MDCG guidance, and the selected conformity assessment route (Annex IX, X, or XI). Key assessment criteria include adequacy of evidence (e.g., complete performance study reports rather than summaries), internal consistency (e.g., alignment between IFU claims and validated performance), and traceability across design, risk management, performance evaluation, and PMS.

Core components examined during the technical file review include the device description and intended purpose, classification rationale, GSPR checklist with linked evidence, risk management documentation, analytical and clinical performance evaluation, verification and validation data, labeling and IFU, PMS and PMPF plans, and vigilance arrangements. For higher-risk devices (Class C and D), particular scrutiny is applied to clinical performance evidence, PMPF justification, and trend detection mechanisms.

The review process typically begins with an administrative and technical completeness check to confirm all Annex II and Annex III elements are present. This is followed by an in-depth technical assessment, issuance of questions or nonconformities where gaps are identified, manufacturer responses with updated documentation, and a final conformity assessment decision once all issues are resolved.

Notified Bodies issue minor nonconformities for issues such as missing references, unclear justifications, or limited inconsistencies, and major nonconformities for fundamental gaps such as insufficient performance evidence, inadequate risk control of incorrect results, or non-compliant labeling. IVD manufacturers are expected to respond with documented corrections, root cause analysis, and corrective actions, as required, and updated technical documentation that directly addresses each finding.

NB communication is formal, documented, and time-bound, with defined response windows established contractually or through NB procedures. Effective responses are structured, address each question individually, reference specific document updates, and provide revised evidence where required to support closure.

NBs verify that Annex II and Annex III documentation is supported by implemented QMS processes assessed under the applicable conformity assessment route. NB assessment includes confirming the alignment between documented procedures and actual practices for change control, risk management, CAPA, PMS, and vigilance, and ensuring that technical documentation reflects effective lifecycle control rather than standalone documentation.

What Support Is Available for IVDR Technical Documentation Preparation and Submission?

Manufacturers preparing IVDR technical documentation can leverage NB-issued submission guides, IVDR Templates, and IVDR checklists in combination with specialist regulatory expertise. NB checklists help ensure that evidence linking is clear for each requirement (e.g., performance claim → supporting study report → IFU statement). Resources from notified bodies help reduce avoidable gaps in Notified Body completeness checks and shorten review times, Q&A cycles, and clock stops. They also help ensure that technical files are compliant with IVDR requirements and meet any Notified Body-specific expectations, such as acceptable document formats or document size limitations.

Support available for IVDR technical documentation preparation and submission is listed below.

• Notified Body Submission Guides: Notified Bodies publish IVDR technical documentation submission guidance that helps manufacturers structure Annex II/III content for efficient assessment (indexing, document naming, expected submission package, and cross-referencing). Examples include guidelines from notified bodies such as BSI’s best-practice guidelines for IVDR submissions and TÜV SÜD’s IVDR technical documentation submission requirements.
• NB-specific Checklists: NB-specific IVDR checklists help manufacturers meet expectations particular to them. Examples include the SGS IVDR Technical Documentation Submission Checklist and TÜV Rheinland’s Annex A checklist, which specifies how evidence should be referenced, including the respective document title, document number, applicable chapter, section, page, etc. IVDR checklists support manufacturers in ensuring that every Annex II and Annex III element is present, easy to locate, and that NB specific expectations are met before the final submission.
• Industry “Best Practice” Guidance for Annex II and Annex III Submissions: Manufacturers should use NB best-practice guidance that reflects common assessment expectations across notified bodies. The purpose is to build a compliant and structured technical file. A leading example is Team-NB’s Best Practice Guidance for the submission of IVDR technical documentation per Annex II and III requirements, which focuses on structuring, evidence linkage, and typical review pain points.
• MDCG Guidance Documents and EU Commission Guidance Library: MDCG documents provide practical interpretation of IVDR requirements that reflect the expected Annex II and Annex III quality (classification rationale, performance evaluation approach, performance study templates). For the purpose of IVDR submissions, the EU Commission’s MDCG library is used as a trusted source to practically interpret IVDR requirements. MDCG provides topic-specific guidance, such as MDCG 2022-2, Guidance on general principles of clinical evidence for IVDs, and MDCG 2020-16, IVDR classification rules, among other topic-specific MDCG guidance.
• Specialist Professionals for Performance Evaluation and Clinical Performance Strategy: Personnel with expertise in clinical science, analytical method validation, biostatistics, and IVDR performance evaluation requirements help ensure Annex XIII performance evaluation evidence is structured, justified, and consistent with IFU claims.

Performance evaluation support typically supports and addresses the most common NB deficiencies, such as weak acceptance criteria rationales, unclear performance study traceability to claims, and inconsistencies between the Performance Evaluation Report (PER) and benefit-risk conclusions.

How Does QMS Software Streamline the Creation and Maintenance of IVDR Technical Documentation?

QMS software supports IVDR compliance by providing a controlled environment to create, manage, and maintain IVDR technical documentation in alignment with Annex II and Annex III requirements. QMS software helps to ensure documentation is complete, version-controlled, traceable, and consistently updated across the device lifecycle, reducing regulatory risk and Notified Body findings.

A medical device QMS platform manages core IVDR technical documentation components, including device description, GSPR checklists, risk management files, performance evaluation documentation, labeling and IFUs, and PMS and PMPF documentation. Each component is maintained as a controlled record with defined ownership, approval workflows, and traceable links to supporting evidence. A medical device QMS software maintains IVDR technical documentation throughout the device lifecycle by linking design changes, CAPAs, PMS signals, and performance updates to affected documentation. This helps to ensure that Annex II and Annex III content remains current, consistent, and audit-ready following post-market or change-driven updates.

SimplerQMS provides an integrated eQMS environment designed for medical device and IVD manufacturers to prepare and maintain IVDR technical documentation in a structured and compliant manner. The platform supports alignment between technical documentation, QMS processes, and lifecycle evidence required under the IVDR.

SimplerQMS Modules and Features useful in preparing and maintaining IVDR technical documents are listed below.

• Controlled Document Management: Maintains Annex II and Annex III Technical Documentation under formal document control, including versioning, approval workflows, and controlled access to prevent use of obsolete content.
• Requirements-to-Evidence Traceability: Establishes traceable links between GSPR requirements, risk management records, performance evaluation evidence, labeling, and PMS outputs to support Notified Body review and inspections.
• Change Control and Impact Management: Ensures design changes, performance updates, or regulatory changes are assessed for impact and trigger timely updates to affected IVDR technical documentation.
• Risk Management and CAPA Alignment: Links risk management activities and CAPA outputs to technical documentation to ensure identified risks, corrective actions, and trend signals are reflected in Annex II and Annex III files.
• Training and Competence Oversight: Monitors training completion and competence of personnel responsible for IVDR technical documentation activities to support consistent and compliant execution of personnel training.
• Audit Trail and Inspection Support: Provides complete audit trails, electronic records, and access controls to demonstrate compliance and support readiness for Notified Body audits and regulatory inspections.