Medical Device Technical File: Definition, Requirements, and Content

A medical device technical file is a structured collection of controlled documents that demonstrates a device’s conformity with applicable regulatory, safety, and performance requirements.

The technical file is a fundamental regulatory requirement under EU MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, and ISO 13485:2016 Clause 4.2.3. A technical file ensures inspection readiness and regulatory traceability throughout the device lifecycle from design and development to post-market surveillance and vigilance.

A compliant technical file follows a standardized format and structure defined by MDR/IVDR Annex II–III or other comparable jurisdiction-specific regulatory requirements. A technical file structure typically includes sections covering device description, intended use, classification, design and manufacturing information, risk management, verification and validation data, clinical or performance evaluation, post-market surveillance, labelling, and QMS certificates.

The technical file must be compiled systematically during development and maintained continuously throughout the device lifecycle. Updates to the technical file are required following design modifications, CAPA implementation, risk management updates, regulatory changes, or the availability of new clinical or PMS data. Controlled updates ensure ongoing conformity and alignment with regulatory requirements.

Common challenges in technical file management include fragmented documentation, inconsistent version control, incomplete risk assessment, and clinical evidence data, to name a few. These challenges are best mitigated through defined ownership, standardized templates, robust document control, and cross-functional collaboration.

An electronic Quality Management System (eQMS) simplifies technical file management by centralizing documentation, automating version control, and ensuring traceability between the different elements of the technical file.

SimplerQMS is a medical device eQMS software that integrates document control, CAPA, change management, training, and supplier management. An eQMS supports compliance with ISO 13485, EU MDR/IVDR, FDA 21 CFR Part 820, and MDSAP requirements, among other requirements, enabling efficient compilation, maintenance, and audit readiness of the medical device technical file throughout the product lifecycle.

What Is a Medical Device Technical File?

A medical device technical file is a structured collection of technical and quality records that demonstrates a device’s conformity with applicable regulatory and quality requirements. The technical file documents all the necessary information to demonstrate that the device is designed, manufactured, and controlled in accordance with its intended purpose and applicable regulatory requirements.

The primary purpose of the technical file is to substantiate regulatory compliance and product conformity. The technical file also enables regulatory authorities, notified bodies, and internal auditors to verify that the device meets the general safety and performance requirements.

The manufacturer is responsible for compiling, maintaining, and updating the technical file within the Quality Management System (QMS). Maintenance and update of the technical file include periodic review, document version control, and timely updates to reflect design or regulatory changes.

The different terms used to refer to a medical device technical file are outlined below.

• Technical Documentation: The term technical documentation is used under the EU MDR 2017/745 and IVDR 2017/746. Technical documentation encompasses the complete body of evidence demonstrating conformity with General Safety and Performance Requirements (GSPRs), including device description, design and development records, manufacturing controls, clinical and performance evaluation, and post-market surveillance documentation.
• Medical Device File: The term medical device file is used in the ISO 13485:2016 standard, which outlines requirements for a medical device QMS. The standard refers to the medical device file as a set of documents with all the required information on design realization, production, verification, and validation, among others.

Why Is the Medical Device Technical File Important?

The medical device technical file is important because it documents how a medical device complies with applicable regulatory requirements, such as the GSPRs under EU MDR or IVDR. A technical file provides evidence of conformity necessary for market authorization.

Legal manufacturers are required to create and maintain a controlled technical file for each device or device family. Authorized representatives must have access to this documentation, and OEMs are responsible for maintaining the technical file when they act as the legal manufacturer.

The technical file is mandatory for conformity assessment and CE marking in the EU, and forms the basis of FDA premarket submissions such as 510(k), De Novo, or PMA.

A technical file contains all the necessary information to ensure the device’s safety and effectiveness. During regulatory audits and inspections, the technical file is reviewed to verify that design, manufacturing, and post-market processes are adequately documented and controlled. The technical file also ensures end-to-end traceability from design inputs and risk management to verification, validation, clinical and performance evaluation, and post-market surveillance.

Failure to maintain a complete or compliant technical file constitutes a major regulatory nonconformity. Under EU MDR/IVDR, a non-compliant technical file can result in certificate suspension or product withdrawal by a Competent Authority. Under FDA jurisdiction, it may trigger Form 483 observations, warning letters, or import holds.

In summary, the technical file is a living regulatory dossier that supports regulatory compliance and sustained market authorization.

When Is a Technical File Required?

A medical device technical file must be established during device design and development and completed before submission for regulatory review or market placement. A technical file documents how the device meets the applicable regulatory requirements and must remain updated throughout the entire lifecycle.

Under the EU MDR and IVDR, the technical documentation is required before the Declaration of Conformity is signed and the CE marking is applied. A technical file supports the conformity assessment procedure outlined in Annex IX, X, or XI and demonstrates compliance with Annex I GSPRs. In the United States, technical documentation is compiled and submitted as part of FDA premarket submissions, such as 510(k) regulatory submissions. Following review of the premarket regulatory submission, a regulatory clearance or approval can be granted.

All device classes require a technical file. The degree of documentation in the technical file, such as testing data and design validation, is based on the device’s risk class. Under EU MDR, class I devices that are non-sterile and non-measuring undergo self-certification by the manufacturer. Class IIa, IIb, and III devices require Notified Body review and assessment of the technical documentation prior to CE marking. Similarly, the FDA expects progressively more extensive design control and validation evidence for higher-risk devices.

A technical file must also be maintained and updated to reflect design changes, manufacturing process updates, software revisions, and intended-use modifications, among others. Each change requires a review, including an impact or gap assessment to determine updates needed in the technical file and ensure continued conformity with the approved design and regulatory requirements.

Each device or device family must be covered by a technical file. Devices within the same family may share a technical file if they have the same intended purpose, risk class, design, and manufacturing process. A technical file is not required only for products that do not qualify as medical devices.

What Are the Requirements for a Medical Device Technical File?

The requirements for a medical device technical file, as per key regulatory legislations, are outlined below.

• EU MDR (Regulation (EU) 2017/745): Under EU MDR, Article 10(4), technical documentation must meet the requirements of Annex II and III. Annexes II and III cover device description, design, and manufacturing information, conformity with Annex I GSPRs, and risk management as per ISO 14971. They also cover verification and validation data, clinical evaluation, labelling, and post-market surveillance documentation.
• EU IVDR (Regulation (EU) 2017/746): Under EU IVDR, technical documentation must meet the requirements of Annex II and III. Technical documentation must also demonstrate conformity with Annex I GSPRs and include detailed analytical and clinical performance evaluation. Risk management, labelling, and Post-Market Performance Follow-up (PMPF) requirements must also be met.
• FDA 21 CFR Part 820 (Quality System Regulation): Under 21 CFR Part 820, Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) need to be established. The documentation therein collectively forms the technical documentation supporting premarket submissions such as the 510(k) or the De Novo.
• ISO 13485:2016: Under Clause 4.2.3, manufacturers must establish and maintain a medical device file containing or referencing all records necessary to describe the device, its specifications, and the QMS processes ensuring device conformity. Documentation must include design, manufacturing, verification, validation, and servicing procedures where applicable.

Comparable technical documentation requirements apply under the UKCA framework, Health Canada Medical Device Regulations SOR/98-282, and Japan’s MHLW Ministerial Ordinance No. 169, among other country-specific requirements. Each legislation requires controlled, auditable records that demonstrate device conformity with applicable safety, performance, and quality requirements.

EU MDR (Regulation (EU) 2017/745)

EU MDR defines requirements for the safety and performance of medical devices. Under EU MDR, technical documentation demonstrates that the device meets the GSPRs in Annex I. The MDR uses the term technical documentation which can be considered equivalent to a technical file.

Technical documentation is required for conformity assessment and CE marking before market placement. Each section of the technical documentation must meet the requirements specified in Annex II and Annex III. Annexes II and III include device description and specification, design and manufacturing information, GSPR checklist, risk management, verification and validation data, clinical evaluation, labelling, and post-market surveillance, among others.

The MDR also requires the technical documentation to be updated based on ongoing post-market surveillance as specified in Annex III. Annex III requires the establishment of Periodic Safety Update Reports (PSURs) based on the device’s risk class. PSURs demonstrate that the device’s benefit-risk rationale remains acceptable.

EU IVDR (Regulation (EU) 2017/746)

EU IVDR defines requirements for the safety and performance of in vitro diagnostic devices (IVD). Under the EU IVDR, technical documentation includes the documents and data that demonstrate that an in vitro diagnostic device complies with the GSPRs in Annex I. Each section of the technical documentation must meet the requirements specified in Annex II and Annex III of the IVDR. The sections comprising the technical documentation include the device description and specification, design and manufacturing details, GSPR checklist, risk management, analytical and clinical performance data, labelling, and post-market surveillance, including Post-Market Performance Follow-up (PMPF).

The IVDR also specifies requirements for scientific validity, analytical performance, and clinical performance evaluation. These elements together form the basis of the IVD’s performance evaluation report (PER). The PER provides objective evidence that the IVD achieves its intended purpose and delivers reliable results under intended use conditions. The PER also supports risk management and ongoing performance verification throughout the device lifecycle.

FDA 21 CFR Part 820 Quality System Regulation

The FDA 21 CFR Part 820 Quality System Regulation (QSR) establishes current good manufacturing practice (cGMP) requirements for medical device manufacturers in the United States. Under 21 CFR Part 820, the equivalent of a technical file is documented through the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR). The DHF, DMR, and DHR together show compliance with design control per 21 CFR part 820.30, production and process control per 21 CFR part 820.70, and Device History Record (DHR) per 21 CFR part 820.184. These files collectively ensure traceability from design input to finished device and support premarket submissions such as 510(k), De Novo, or Premarket Approval (PMA).

21 CFR Part 820 also specifies requirements for CAPA per 21 CFR Part 820.100 and complaint handling per 21 CFR Part 820.198, ensuring post-production feedback and issues are systematically addressed. While the FDA does not use the term ‘technical file’, the DHF, DMR, and DHR collectively serve the same purpose as the technical file under the MDR, demonstrating that a device’s design, manufacturing, and performance comply with regulatory requirements.

ISO 13485:2016

ISO 13485 is an international standard that specifies quality management system (QMS) requirements for organizations involved in the lifecycle of medical devices. Under ISO 13485:2016, manufacturers must maintain a Medical Device File that describes the device, its specifications, and the QMS processes ensuring conformity.

Technical file requirements are defined in Clause 4.2.3 Medical Device File and supported by design and development controls in Clause 7.3, production and process controls in Clause 7.5, and feedback and CAPA processes in Clause 8. The Medical Device File includes design specifications, manufacturing procedures, test and inspection methods, labelling, installation, and servicing information, where applicable. ISO 13485 integrates this file within the QMS, maintained under document and change control. Compliance is demonstrated through Clauses 4.2.4 and 4.2.5, ensuring all documentation remains current and traceable.

What Is the Medical Device Technical File Format?

A medical device technical file is a structured, indexed document set that demonstrates a device’s conformity with applicable regulatory requirements. The technical file must provide full traceability from design inputs through to post-market data.

The structure and layout of the technical file must follow a clear and consistent medical device folder structure. Top-level sections of the technical file include device description and specification, design and manufacturing information, GSPRs, risk management, design verification and validation, clinical or performance evaluation, labelling, and post-market surveillance (PMS).

There is no single global template for the establishment of a technical file. However, regulatory authorities expect a coherent, cross-referenced dossier in accordance with their respective legislations.

For regulatory submissions, a folder hierarchy structured to reflect the applicable conformity assessment or submission pathway could be used. The submission can be supported by a detailed table of contents, document register, and a requirements-to-evidence matrix. An evidence matrix cross-references each regulatory requirement to the corresponding controlled record.

Under EU MDR and IVDR, technical documentation includes a GSPR checklist and follows the elements listed in Annex II–III.

As per FDA requirements, the technical documentation is demonstrated through the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) maintained under the Quality System Regulation 21 CFR Part 820. Premarket submissions such as 510(k), De Novo, or Pre-Market Approval (PMA) must be compiled and submitted using the FDA eCopy or electronic submission format.

What are the Contents of a Medical Device Technical File?

The contents of a medical device technical file aligned with EU MDR/IVDR Annex II–III, ISO 13485:2016 Clause 4.2.3, and FDA 21 CFR Part 820 are listed below. 

1. Device Description and Specifications: Provides a detailed overview of the device, including trade name, model, intended purpose, configuration, variants, and accessories. The device description and specification section includes information on the device’s technical characteristics, key components, and principles of operation to establish device identification.
2. Intended Use and Indications: Defines the medical purpose, target population, precautions, contraindications, and conditions of use. Intended use and indications support correct device classification, clinical evidence gathering, and labelling claims.
3. Classification and Conformity Assessment Route: Specifies the device class according to applicable regulatory requirements, such as MDR Annex VIII requirements. The section must outline the conformity assessment procedure followed.
4. Design and Manufacturing Information: Describes the device’s design and manufacturing processes, materials, and production environment controls. Design and manufacturing also include information on supplier management, process validation, and traceability of critical components, consistent with ISO 13485 design and production control requirements.
5. Risk Management Documentation (ISO 14971): Describes the device’s risk management process, referencing the risk management file maintained per ISO 14971. The risk management file must demonstrate that all identified risks and possible failure modes are documented and controlled. Residual risks must also be acceptable in relation to the device’s intended benefits.
6. Safety and Performance Requirements / Design Controls Mapping: Safety and performance requirements in the EU are demonstrated through a GSPR Checklist. The GSPR checklist is a table showing compliance with all Annex I safety and performance requirements. Each requirement is cross-referenced to supporting evidence such as design, risk management, and verification data. For the U.S., compliance is demonstrated through design controls mapping under 21 CFR 820.30.
7. Verification and Validation Data: Describes the results of design verification and validation activities, such as performance testing, software validation, and biocompatibility assessments as per relevant standards. Documentation must have all the testing data to show that the device meets applicable design and safety specifications under expected operating conditions.
8. Clinical Evaluation or Performance Evaluation: Provides clinical or performance evidence supporting safety and performance claims. The documentation includes clinical evaluation reports (CER) for MDR devices or performance evaluation reports (PER) for IVDR devices, with references to clinical data, peer-reviewed scientific literature, or equivalence data, where applicable.
9. Post-Market Surveillance (PMS) and Vigilance: Describes the documentation to support monitoring of device performance after-market placement. The PMS and vigilance section must include the PMS plan, vigilance reporting procedures, and outputs such as the Periodic Safety Update Report (PSUR) or Post-Market Performance Follow-up (PMPF) plan, as required.
10. Labelling, IFUs, and Packaging Information: Contains finalized labelling, packaging artwork, and instructions for use (IFU) that meet the regulatory and language requirements of the target market. This section must also document specific requirements for Unique Device Identification (UDI) and labelling to ensure device traceability.
11. Quality Management System Certificates: Includes valid QMS certifications, such as ISO 13485:2016 certificates or MDSAP audit reports, where applicable. These documents provide evidence that the manufacturer maintains a compliant, independently audited quality management system that meets applicable regulatory and quality system requirements.

1. Device Description and Specifications

The device description and specifications section defines the medical device, device configuration, and key technical characteristics. The device description and specifications ensure that the description of the device aligns with other supporting documentation in the technical file, such as design records, risk management, and clinical evidence.

Core components include the device name, model or catalogue number, intended purpose, design configuration, principles of operation, and a description of any variants, accessories, or software components included within the scope.

Under EU MDR Annex II, Section 1 and EU IVDR Annex II, Section 1, manufacturers must include detailed device descriptions as part of the technical documentation. Equivalent expectations apply under FDA 21 CFR Part 820.30 Design Controls. The section should be structured using a version-controlled format supported by diagrams, product photos, and technical drawings illustrating key components.

Typical supporting documents include the device overview, configuration matrix, functional specifications, and block or schematic diagrams clarifying how the device achieves its intended function.

2. Intended Use and Indications

The intended use and indications section defines the medical purpose and clinical application of the device. The intended use and accompanying indications specify what the device is designed to do, who it is intended for, and under what conditions it should be used. This section forms the foundation for the device’s classification, clinical evaluation, labelling, and claims substantiation.

Core elements include the device’s intended medical purpose, target patient or user population, indications, precautions, or contraindications. The intended use should also describe the mode of action and any physiological or anatomical principles the device uses to achieve its intended use. The purpose is to ensure alignment of the intended use with design controls, risk management, and clinical evidence.

The requirements for the intended purpose are stated under EU MDR and IVDR Annex II, Sections 1.1(a) and 1.1(c). Comparable provisions exist under FDA 21 CFR Part 820.30(c). Intended use and indication are central to the device’s risk classification and subsequent regulatory submissions. Under ISO 13485:2016, Clause 4.2.3, the Medical device file shall include a description of the intended use/purpose.

The intended use should be written as a concise narrative supported by clear, consistent terminology. The description must match the labelling, IFU, and clinical evaluation report to avoid discrepancies during regulatory review.

3. Classification and Conformity Assessment Route

EU MDR classification and EU IVDR classification, together with the selected conformity assessment route, define the device’s risk class and the procedure used to demonstrate regulatory conformity. The classification and conformity assessment route also determines the level of Notified Body involvement and the extent of regulatory review required for market authorization.

Core components include the device risk class, classification rationale, and the regulatory pathway chosen under the applicable regulatory requirements. Devices are classified under Annex VIII of the EU MDR or IVDR based on their intended use, invasiveness, duration of contact, and overall risk. EU MDR Article 52 and IVDR Article 48 define the conformity assessment requirements for medical devices and IVDs. Manufacturers follow the conformity assessment route under Annex IX for most medium- to high-risk devices, which involves assessment of the QMS and technical documentation. For higher-risk or custom devices, Annex X requires independent type examination, while Annex XI is used for product conformity verification of individual devices or batches.

The purpose of the classification and conformity assessment section is to justify the device’s regulatory position and ensure alignment between its intended use, risk profile, and applicable conformity assessment requirements.

As per FDA requirements, medical devices are classified into Class I, II, or III based on their risk level. The risk classification and degree of device novelty determine the required premarket pathway, such as 510(k), De Novo, or PMA.

The classification and conformity assessment section should present the information in a concise and traceable format. An acceptable format includes a classification rationale table citing which classification rules apply, justification for rule selection, and applicable conformity route. Supporting documentation commonly includes the classification rationale and a conformity assessment summary.

4. Design and Manufacturing Information

The design and manufacturing information section documents how the device is designed, developed, and manufactured under controlled QMS processes. Design and manufacturing information describes the design architecture, components, materials, and production controls applied to ensure consistent product quality.

Core elements include design drawings, specifications, manufacturing flowcharts, and details on critical suppliers and subcontractors.

The purpose of the design and manufacturing section is to provide objective evidence that the device’s design and production processes are validated, reproducible, and compliant with regulatory requirements. Design input and manufacturing data links directly to risk management, verification, and validation data, demonstrating that design intent is realized in production.

Design and manufacturing requirements correspond to EU MDR Annex II, Section 3, and IVDR Annex II, Section 3, and align with FDA 21 CFR Part 820 Design Controls and Production Controls as well as ISO 13485:2016 Clauses 7.3 and 7.5. The design and manufacturing section should be organized logically, following the sequence of design inputs, outputs, design reviews, and manufacturing process descriptions.

5. Risk Management Documentation per ISO 14971

The risk management documentation section summarizes how risks associated with the device have been identified, evaluated, and controlled throughout the lifecycle. The risk management section references the full risk management file maintained per ISO 14971.

Core elements include hazard identification checklists, risk analysis, risk control measures, and evaluation of residual risks. The purpose is to demonstrate that risk controls are implemented, verified, and that residual risks are acceptable in relation to clinical benefits. The section also maintains traceability between design controls, verification, and validation, and post-market activities.

Risk management requirements correspond to EU MDR Annex II, Section 5, and IVDR Annex II, Section 5, and align with ISO 13485:2016 Clauses 7.1 and 7.3.3. The risk management section should organize and reference documentation, such as the risk management report, providing a clear record of risk assessment, risk control measures, and verification of residual risks.

Key guidance documents include ISO 14971:2019, ISO/TR 24971. Common supporting records include hazard identification tables, FMEA tables, risk assessments, and residual risk evaluation matrices.

6. Safety and Performance Requirements / Design Controls Framework

The safety and performance requirements / design controls section demonstrates how the device complies with all applicable regulatory safety and performance requirements. For the EU, compliance is demonstrated through a GSPR Checklist, as required by Annex I of the MDR/IVDR. The checklist cross-references each GSPR clause to supporting evidence such as design documentation, risk management files, verification and validation reports, and post-market surveillance records, ensuring full traceability of conformity.

For the U.S., compliance is demonstrated through the design controls framework under 21 CFR 820.30. The design controls framework establishes traceability between design inputs, outputs, verification, validation, and risk management activities within the Design History File (DHF) to the defined safety and performance objectives.

7. Verification and Validation Data

The verification and validation data section contains documented evidence confirming that the device meets its design, safety, and performance specifications. The verification and validation section demonstrates that all verification and validation activities have been completed according to approved plans and methods.

Core elements include design verification results, process and software validation, biocompatibility testing, and electrical and mechanical safety test reports. For sterile or software devices, sterilization validation or software validation evidence must be included.

Verification and validation data provide objective evidence that the device conforms to the GSPRs as per MDR or equivalent requirements in other regulatory jurisdictions. Verification and validation documentation should maintain clear traceability to risk management, design outputs, and product realization.

The verification and validation requirements correspond to EU MDR Annex II, Section 6, and IVDR Annex II, Section 6. Corresponding FDA requirements are 21 CFR 820.30(f) Design Verification and 21 CFR 820.30(g) Design Validation. Corresponding ISO 13485:2016 requirements are Clause 7.3.6. and 7.3.7. The verification and validation section should be structured with summary tables referencing test reports and validation protocols, ensuring traceability to design inputs.

Applicable standards for verification and validation include IEC 60601, ISO 10993 series, IEC 62304, and IEC 62336-1, to name a few, depending on device type. Typical documentation includes verification and validation plans, test protocols, verification and validation reports from both in-house and external facilities, including any validation summaries demonstrating compliance with relevant standards and applicable regulatory requirements.

8. Clinical Evaluation or Performance Evaluation

The clinical evaluation (MDR) or performance evaluation (IVDR) section provides evidence that the device achieves its intended clinical or analytical performance and safety under normal conditions of use. Clinical and performance evaluations gather and assess clinical or device performance data, peer-reviewed scientific literature, and, where applicable, clinical study results to support the device’s benefit-risk determination.

Core components include the clinical evaluation plan (MDR) or performance evaluation plan (IVDR), which outlines the objectives, scope, and methodology of the evaluation process. Through the data Identification and appraisal process, the quality, validity, and relevance of available evidence are assessed. The Clinical Evaluation Report (CER) or Performance Evaluation Report (PER) consolidates all appraised evidence to support the device’s intended use and benefit-risk profile.

This requirement corresponds to EU MDR Annex XIV, Part A and EU IVDR Annex XIII, Part A. Other relevant requirements and standards include FDA 21 CFR 812 for clinical investigations and ISO 14155 for clinical study conduct.

Relevant guidance includes MEDDEV 2.7/1 Rev. 4, MDCG 2020-13, and Clinical evaluation assessment report template. Common documents include Clinical Evaluation Reports (CERs) or Performance Evaluation Reports (PERs), literature search strategies, post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) plans and reports.

9. Post-Market Surveillance and Vigilance

The Post-Market Surveillance (PMS) section outlines how the manufacturer monitors and evaluates device performance once placed on the market. The post-market surveillance section describes processes for collecting, analyzing, and acting upon feedback, complaints, and adverse event data to ensure continued compliance and patient safety.

The PMS and Vigilance section describes the manufacturer’s PMS system, including procedures for gathering and analyzing customer feedback, complaints, and incidents. The purpose is to demonstrate a systematic and proactive approach to monitoring post-market data, identifying risks, and implementing corrective and preventive actions (CAPA) to ensure continued device safety and performance.

PMS and vigilance requirements are defined in EU MDR Annex III and IVDR Annex III and align with ISO 13485:2016 Clause 8.2. Corresponding FDA requirements include 21 CFR 803 Medical Device Reporting and 21 CFR 820.198 for complaints. The PMS and vigilance section should include PMS procedures, reporting timelines, and link to CAPA and risk management processes.

Applicable guidance includes MDCG 2023-3 on vigilance terms and concepts, and MDCG 2022-21 on PSURs. Common documentation includes PMS plans, PSURs, PMCF or PMPF reports, vigilance reports, and records of trend analysis or CAPA records.

10. Labelling, Instruction For Use (IFU), and Packaging Information

The Labelling, IFU, and Packaging Information section compiles all materials used to communicate device information and safety details to users. The IFU, packaging, and labelling must comply with language, symbol, and traceability requirements applicable to each intended market where the device is placed.

Core elements include final labelling artwork, IFUs, outer packaging designs, and Unique Device Identification (UDI) information. The purpose is to confirm that labelling content is consistent with the intended use, risk management outputs, and applicable regulatory requirements.

This requirement corresponds to EU MDR Annex I, Chapter III, Section 23, IVDR Annex I, Chapter III, Section 20, and FDA 21 CFR Part 801 Labelling. Labels, IFUs, and packaging information must also meet requirements as per ISO 15223-1, Symbols and ISO 20417, Information to be Supplied by the Manufacturer, where relevant.

The labelling, IFU, and packaging section should be structured by labelling type, such as primary, secondary, IFU, and e-labelling, if applicable. Common documentation includes approved labelling templates, language versions, UDI records, and label approval records controlled under the QMS.

11. Quality Management System Certificates

The QMS certificates section provides evidence that the manufacturer operates a QMS compliant with applicable regulatory requirements and standards. QMS certifications demonstrate that the QMS governing the device lifecycle is independently verified.

Core documents include valid ISO 13485:2016 certificates, MDSAP audit reports where applicable, and Notified Body QMS or CE certificates referencing the applicable conformity assessment route. The purpose is to confirm regulatory oversight and the manufacturer’s capability to maintain consistent product quality and compliance.

QMS certification and related Notified Body assessments support conformity with the MDR/IVDR and align with FDA 21 CFR Part 820 QSR. QMS certificates support continued market authorization and audit readiness by verifying that QMS processes remain effective and certified.

The QMS certificates section should include current certificates, scope statements, and audit summaries. Typical documentation includes ISO 13485 certificates, MDSAP audit reports, and Notified Body certificates, to name a few.

How to Compile a Medical Device Technical File?

To compile a medical device technical file, consider following the steps listed below.

1. Define the File Structure: Establish a clear folder hierarchy and index aligned with the required submission format, such as MDR/IVDR Annex II–III or the Notified Body’s specific template. Maintain a consistent layout across all device files to ensure efficient document retrieval and review.
2. Develop a Master Document Checklist: Create a checklist referencing all the required elements, such as device description, risk management, verification and validation, clinical/performance data, and PMS documentation. This serves as the master reference for completeness and regulatory traceability.
3. Collect Core Design and Manufacturing Documentation: Gather all design control records, manufacturing procedures, material specifications, and process validation evidence. These documents must demonstrate conformity with applicable regulatory requirements, such as the FDA’s quality system requirements.
4. Compile Risk and Clinical Documentation: Integrate the risk management file per ISO 14971 and clinical or performance evaluation reports per MDR Annex XIV or IVDR Annex XIII. Ensure traceability between identified risks, verification/validation data, and clinical evidence.
5. Include Quality and Regulatory Certificates: Attach valid ISO 13485, MDSAP, or Notified Body QMS certificates relevant to the conformity assessment route. Certificates serve as verified proof to demonstrate that the manufacturer operates under a certified and compliant quality management system.
6. Perform Cross-Functional Review: Conduct internal review with input from RA/QA, clinical, engineering, and manufacturing teams. This ensures that regulatory claims, IFU information, risk controls, and quality records align before formal approval.
7. Validate Completeness with Regulatory Cross-Check: Use a cross-reference matrix mapping each regulatory requirement, such as MDR Annex I GSPRs, to supporting evidence in the file. This confirms completeness and facilitates regulatory review.
8. Apply Document Control and Version Management: All documents must be controlled within the QMS and meet applicable document control requirements. Document Control requirements include ISO 13485 Clauses 4.2.4 and 4.2.5. Assign document numbers, revision history, approval signatures, and metadata to ensure traceability and prevent the use of outdated records.
9. Convert and Organize for Submission: Prepare the final submission package according to regulatory requirements. Examples include Annex II–III structure for EU MDR/IVDR, Notified Body’s submission structure, or FDA eSTAR structure for most 510(k)/De Novo submissions. Ensure all documents are searchable, indexed, and properly labelled.
10. Prepare for Audit or Review: Ensure the technical file is readily accessible to Notified Bodies, Competent Authorities, or the FDA during inspection. Maintain quick-reference indexes, version logs, and evidence matrices that map evidence to requirements to support efficient review.
11. Maintain and Update the File Continuously: Update the file throughout the device lifecycle to reflect design changes, PMS findings, or other regulatory updates. Continuous maintenance ensures sustained conformity and inspection readiness.

What Are the Challenges in Compiling Technical Files?

Challenges typically encountered while compiling a technical file are listed below. 

• Fragmented Documentation Across Teams: Design, regulatory, clinical, and manufacturing records are often stored in separate systems or departments. Fragmented documentation makes it difficult to ensure consistency, traceability, and completeness across the technical file.
• Poor Version Control and Traceability: Uncontrolled revisions or missing document histories can compromise the integrity of technical file documentation. Lack of version control increases the risk of submitting outdated or inconsistent records to regulatory authorities.
• Unclear Responsibilities and Ownership: When file ownership is undefined, essential documents may be delayed, omitted, or remain outdated. Establishing clear accountability for document creation, review, and approval within the QMS is critical for compliance.
• Regulatory Misalignment: Files compiled without reference to current EU MDR/IVDR Annex II–III, FDA submission requirements, or a notified body’s specific technical file requirements often fail to meet regulator expectations. Regulatory misalignment can lead to nonconformities, requests for additional data, and delays in market authorization.
• Incomplete Risk or Clinical Documentation: Missing or outdated risk management or clinical/performance evaluation documentation can compromise the assessment of a device’s benefit-risk ratio. Incomplete risk or clinical documentation may raise concerns regarding device safety, performance, and overall regulatory compliance.
• Lack of Cross-Functional Review: Joint review by RA/QA, engineering, clinical, and manufacturing teams is essential for a complete and updated technical file. Lack of cross-functional review results in inconsistencies between design data, labelling, and clinical claims.
• Manual Compilation Processes: Manual document handling, spreadsheets, or uncontrolled file storage increases the likelihood of errors and missing links. Digital QMS solutions streamline control, traceability, and updates for submission audit readiness.
• Failure to Maintain Ongoing Update: Technical files must reflect the current state of design, manufacturing, and post-market data. Failure to update the technical file following design changes, CAPAs, or PMS results is a common cause for nonconformities.

What Are the Best Practices in Compiling Technical Files?

The best practices in compiling technical files are listed below.

• Follow Regulatory Checklists: Use regulatory checklists based on MDR/IVDR Annex II–III or a checklist provided by the legal manufacturer’s specific Notified Body. Detailed checklists ensure that the technical documentation meets the structure and scope expected by regulators and Notified Bodies.
• Use Standardized Templates: Adopt controlled templates for key sections such as risk management, clinical/performance evaluation, and design control documentation. Standardized formats ensure uniform documentation quality across projects.
• Centralize Document Control: Manage all records and documents under the QMS with defined document control procedures per ISO 13485 Clauses 4.2.4 and 4.2.5. Centralization prevents duplication, ensures version accuracy, and supports efficient access to documents during audits.
• Assign Section Owners: Designate responsible owners for each section of the file. RA must be involved for regulatory aspects such as clinical evaluation documentation, QA for risk management and CAPA reports, and engineering for design control documentation. Defined ownership ensures accountability and timely updates of all technical file sections.
• Maintain a Clear Folder Structure: Use a standardized folder hierarchy and index reflecting regulatory requirements. For example, MDR Annex II and III requirements or a technical file structure provided by the Notified Body. A consistent technical file structure simplifies navigation, supports traceability, and enables efficient review by competent authorities or Notified Bodies.
• Review and Update Regularly: Schedule periodic internal reviews to confirm that documents reflect current design, production, and post-market conditions. Updates to the technical file following design changes, CAPAs, or PMS findings are essential for ensuring continuous conformity.
• Ensure Internal Consistency: Cross-check that information is consistent across sections such as intended use, risk management, labelling, and clinical evaluation. Consistency reduces regulatory findings and ensures that claims are supported by valid evidence.
• Track Version History: Maintain full revision logs for all controlled records, including approval signatures and dates. Accurate version history provides traceability, supports audit verification, and confirms that only approved documents are in active use.

When Should a Medical Device Technical File Be Updated?

Changes that require a technical file to be updated are listed below.

• Design or Engineering Changes: Any modification to the device design, materials, components, or software requires an update. Engineering and RA are responsible for ensuring that design outputs, risk management, and verification/validation data are revised and controlled.
• Manufacturing Process Changes: Changes to production methods, equipment, suppliers, or critical process parameters must be documented. QA and Manufacturing lead the update, supported by process validation reports and updated manufacturing documentation.
• Corrective and Preventive Actions (CAPA): CAPA implementation that affects device conformity, labelling, performance, or safety triggers a technical file revision. QA oversees the incorporation of updated risk assessments, verification, and validation evidence, CAPA records, and any associated procedural change.
• Risk Management or New Hazard Identification: Identification of new risks or changes in residual risk requires updates to the risk management file. QA and RA ensure changes are reflected in risk-benefit analysis, risk control measures, and traceability matrices.
• Clinical or Performance Data Updates: New clinical evidence, performance data, or literature reviews affecting device safety, effectiveness, or claims must be integrated. Clinical Affairs and RA update the Clinical Evaluation Report (CER) or Performance Evaluation Report (PER) and ensure alignment with labelling and IFU.
• Labeling, IFU, or Packaging Modifications: Revisions to labelling content, symbols, or translations require corresponding updates to the labelling section. RA and QA ensure compliance with applicable language, UDI, and regulatory requirements.
• Regulatory Changes or Renewals: When regulations, standards, or certificates change, the file must be reviewed for continued alignment. RA ensures the incorporation of new conformity assessment routes, standards, or QMS certificates.
• Post-Market Surveillance (PMS) and Vigilance Findings: Updates from PMS reports, PSURs, PMCF/PMPF activities, or vigilance events must be captured. QA and Clinical Affairs ensure feedback is integrated into risk management and CAPA systems.
• Notified Body or Authority Feedback: Requests from Notified Bodies, Competent Authorities, or the FDA for clarification or corrective actions require immediate file review and updates. RA manages these updates and ensures documentation traceability.

Version history, approval records, and document metadata must be maintained to ensure audit readiness and regulatory traceability. Controlled change records should link to related CAPA, change control, or management review actions.

An electronic quality management system (eQMS) centralizes documentation, workflows, and approvals. It automates version control, maintains audit trails, and enables cross-references between design, risk management, and regulatory documentation to ensure full traceability.

What Is the Difference Between a Technical File and a Design Dossier?

The key difference between a design dossier and technical documentation lies in their regulatory framework and scope. Under the former EU MDD (93/42/EEC), Class III devices required a Design Dossier containing full design and development data for Notified Body design examination. Under the EU MDR (2017/745), this has been replaced by technical documentation, which applies to all device classes and follows a standardized structure under Annex II and III.

While both include similar content, the MDR technical documentation requires stronger traceability and lifecycle integration between design, risk management, verification, validation, and post-market activities. The design dossier remains relevant for legacy Class III devices still certified under the MDD, with certificates valid until December 2027 or December 2028, depending on the device class, under the MDR transition provisions. In the U.S., equivalent design control documentation is maintained within the DHF under 21 CFR 820.30.

What Is the Difference Between a Technical File and a DHF?

The main difference between a technical file and a design history file (DHF) lies in their regulatory origin and intended purpose. A technical file is required under the EU MDR/IVDR to demonstrate conformity with safety and performance requirements. A design history file is required under the U.S. FDA Quality System Regulation, 21 CFR Part 820, to document design control activities.

A DHF contains all records showing that the device design was developed according to an approved design plan and applicable regulatory requirements. A DHF serves as proof of design control compliance, covering inputs, outputs, verification, validation, design reviews, and design transfer. A technical file is broader in scope and includes additional information apart from design and development records. A technical file also covers manufacturing information, risk management, clinical evidence, labelling, and post-market surveillance data.

The FDA requires a DHF for all medical devices marketed in the U.S. In the EU, a technical file is required for all devices under the EU MDR/IVDR, reviewed by Notified Bodies based on the device’s classification.

The technical file and DHF complement each other across the product lifecycle. The DHF provides design history and control evidence. The technical file demonstrates ongoing regulatory compliance and product performance throughout the device’s lifecycle.

How Does Medical Device eQMS Support Compilation and Maintenance of a Technical File?

A medical device electronic quality management system (eQMS) is a digital platform that centralizes and automates quality and regulatory processes within an organization. An eQMS enables manufacturers to compile, control, and maintain their technical file efficiently and supports compliance with EU MDR/IVDR, FDA QSR, and ISO 13485:2016 requirements.

A medical device eQMS improves efficiency with automated workflows, robust document control capabilities, and secure data traceability. An eQMS helps ensure that every document contributing to the technical file, such as design, risk, clinical, or post-market elements, is current and version-controlled.

Key eQMS capabilities that support technical file management are listed below.

• Document Control and Version Management: Automates approvals, maintains revision history, and prevents the use of outdated documents.
• Traceability and Linkage: Ensures appropriate linkage between design controls, risk assessments, verification data, and CAPAs to the relevant technical file sections for full lifecycle traceability.
• Regulatory Compliance Alignment: Provides configurable templates and workflows structured in line with the documentation requirements of MDR/IVDR Annex II–III, ISO 13485, and FDA 21 CFR Part 820.
• Training and Competence Management: Tracks training completion and qualification of personnel involved in technical documentation activities, supporting compliance with the necessary competence requirements.
• Audit Trail and Access Control: Captures all user actions and manages access permissions, ensuring data integrity and readiness for audits or inspections.

SimplerQMS is a fully validated eQMS software for medical device companies, designed to streamline and connect quality and regulatory processes across the organization. SimplerQMS supports end-to-end QMS processes such as document control, change management, CAPA, training, supplier management, audit management, and others. The system also facilitates the structured compilation, control, and maintenance of technical documentation (technical files), helping manufacturers demonstrate compliance with ISO 13485:2016, EU MDR/IVDR, FDA 21 CFR Part 820 (QSR), MDSAP, and related regulatory requirements. It ensures records remain accurate, traceable, and up to date throughout the device lifecycle.