Understanding STED in Medical Device Applications

Introduction

To introduce medical devices to the market, review and approval by regulatory authorities in each country or region are required. A crucial document in this application process is the “STED (Summary Technical Documentation).”

STED is an abbreviation for “Summary Technical Documentation,” which compiles the technical information necessary to evaluate the safety and effectiveness of medical devices. Originally proposed by the Global Harmonization Task Force (GHTF), its development is now carried forward by the International Medical Device Regulators Forum (IMDRF). This is a standardized document format designed to promote consistency and efficiency in reviews among regulatory authorities worldwide.

In Japan, it is referred to as “STED,” in Europe as “Technical Documentation,” and in the United States, similar technical documents are required as part of “510(k)” or “PMA” submissions. However, with recent international harmonization efforts, the basic requirements are becoming increasingly aligned.

Important Note on Current Regulatory Landscape: Transition from STED to IMDRF Table of Contents

While this article uses the term “STED” to describe technical documentation for medical devices, it is important to note that the regulatory landscape has evolved significantly since the original STED format was established by GHTF in 2007.

Current Global Situation: Many major markets have now transitioned from the traditional STED format to the IMDRF Table of Contents (ToC) format. The IMDRF developed two versions of the ToC:

• Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) – currently in its 4th edition as of June 2024
• In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)

Markets That Have Adopted IMDRF ToC:

• Canada: Mandated IMDRF ToC format for Class II, III, and IV applications since April 1, 2019, with STED format discontinued
• Australia: TGA has adopted the IMDRF ToC with classification matrices
• Brazil: ANVISA has transitioned to IMDRF ToC-based requirements
• China: New regulations based on IMDRF (Order #739) implemented in June 2021
• Saudi Arabia: Regulations closely resemble EU MDR with ToC-aligned requirements
• Nigeria: NAFDAC announced transition from STED to IMDRF ToC in 2024

Markets Using Alternative Formats:

• ASEAN Countries: Use ASEAN Common Submission Dossier Template (CSDT), which is similar to IMDRF ToC but uses different numbering. Separate versions exist for medical devices and IVD. Singapore’s Health Sciences Authority (HSA) is considered the gold standard for regulatory submission processes in the ASEAN market.
• European Union: EU MDR/IVDR requires Technical Documentation as specified in Annex II and Annex III, which aligns conceptually with IMDRF principles but has specific EU requirements

Japan’s Current Position: Japan continues to use the STED format as the basis for its submission requirements, making it one of the major markets that has not yet fully transitioned to the IMDRF ToC format. Japanese submissions are still referred to as “STED” by regulatory authorities and industry, though they incorporate IMDRF principles and must be submitted in Japanese language.

Why This Matters:

• Companies seeking global market access need to understand which format each target market requires
• The IMDRF ToC provides over 150 chapters and sub-chapters with more defined requirements than the original STED
• The ToC format uses a matrix system indicating whether sections are Required (R), Conditionally Required (CR), Not Required (NR), or Optional (O) based on submission type and risk classification
• This transition reflects evolving regulatory expectations for more comprehensive and structured technical documentation

Throughout this article, “STED” refers to the general concept of summary technical documentation, while recognizing that specific format requirements vary by jurisdiction.

Relationship Between Application Overview and STED

In the approval application for medical devices, there are two important documents: the “Application Overview” and the “STED.” While these are closely related, they serve different roles.

The Application Overview is a document attached to the medical device approval application and serves as a summary document to grasp the overall picture of the review. It concisely summarizes information such as the development background, design, performance, safety, and clinical positioning of the medical device. This document is often the first to be reviewed by examiners and plays an important role in determining the direction of subsequent detailed reviews.

On the other hand, STED is a detailed technical document that supports the Application Overview, providing scientific and technical justification for the content described in the Application Overview. STED is more detailed and comprehensive than the Application Overview and is positioned as a document for detailed review by examiners with technical expertise.

To express the relationship between the two concisely, the Application Overview shows the overall picture of “what is being applied for,” while STED is a document that explains in detail “why it is safe and effective.” Applicants are required to ensure consistency between the two documents and provide a coherent explanation.

Roles and Importance of STED

STED fulfills the following roles:

Information Provision to Regulatory Authorities: By systematically presenting information about the design, manufacturing, performance, and safety of medical devices, it becomes the foundation for regulatory authorities to conduct appropriate reviews.

Promotion of International Harmonization: By adopting a common format, the application process in different countries and regions can be made more efficient. This allows medical device manufacturers to reduce the burden of applications to multiple countries.

Demonstration of Risk Management: By documenting the identification, assessment, and mitigation measures for risks related to medical devices, it demonstrates the commitment to ensuring product safety.

Product Lifecycle Management: Documents a consistent management system from design to post-market surveillance.

Support for Application Overview: By providing detailed scientific and technical justification for the claims and performance characteristics described in the Application Overview, it enhances the reliability and efficiency of the review.

Components of STED/Technical Documentation

Standard STED or technical documentation consists of the following elements (note that specific requirements may vary depending on whether STED, IMDRF ToC, or other formats are used):

Device Description and Specifications

• Overview of the medical device, intended use, classification
• Basic principles and operating mechanisms
• Product specifications and performance characteristics

Design and Manufacturing Information

• Overview of design process
• Manufacturing methods and quality management system
• Information on key suppliers and subcontractors

Non-Clinical Test Data

• Physical and chemical property testing
• Electrical safety and electromagnetic compatibility testing
• Biological safety assessment
• Stability testing
• Software verification and validation (where applicable)

Clinical Evaluation Data

• Clinical trial results
• Literature review
• Clinical experience

Risk Analysis and Management

• Risk analysis methodology
• Identified risks and their mitigation measures
• Risk-benefit analysis

Labeling and Package Inserts

• Labeling information
• Instructions for use
• Promotional materials

Characteristics of STED Submission in Japan

In Japan, the STED format for applications was introduced in 2005 and is positioned as part of pharmaceutical applications (currently applications based on the Pharmaceuticals and Medical Devices Act). Characteristics of STED submissions in Japan include the following:

Requirements According to Class Classification: The level of detail of required information varies depending on the class classification of the medical device (I to IV). Higher-risk devices require more detailed information.

Conformity to Essential Principles: It is necessary to demonstrate conformity to Japan’s unique “Essential Principles.” This reflects Japan-specific regulatory requirements while adhering to international basic principles.

Utilization of PMDA Consultation System: By utilizing the face-to-face consultation system by the Pharmaceuticals and Medical Devices Agency (PMDA), it is possible to share understanding with regulatory authorities before submission. This system contributes to improving the quality of applications and streamlining reviews.

Language Requirements: All submission documents must be prepared in Japanese, including the STED summary.

Integration with Japanese Standards: Submissions must reference compliance with applicable Japanese Industrial Standards (JIS) and international standards recognized by PMDA.

Key Points in Creating STED/Technical Documentation

Important points in creating STED or technical documentation include:

Consistent Document Structure: Pay attention to the overall document structure so that technical information is presented logically and consistently.

Adoption of Risk-Based Approach: Based on the risk characteristics of the product, identify items that should be emphasized and provide detailed information.

Proof of Conformity to Standards and Guidelines: Clearly demonstrate conformity to relevant international standards (ISO, IEC, etc.) and guidelines of each country. Common standards include:

• ISO 14971 (Risk Management)
• ISO 13485 (Quality Management Systems)
• IEC 62304 (Medical Device Software – Software Life Cycle Processes)
• ISO 10993 series (Biological Evaluation of Medical Devices)

Appropriate Citation of Evidence: Properly cite evidence such as test results and literature data that support claims, and ensure traceability.

Ensuring Transparency: Honestly mention uncertainties and limitations, and indicate measures to address them.

Format-Specific Requirements: When preparing submissions:

• For IMDRF ToC format: Follow the specific numbering structure and use the applicable classification matrix (R/CR/NR/O)
• For EU MDR: Ensure compliance with Annex II or Annex III requirements
• For ASEAN CSDT: Follow the CSDT-specific structure and numbering
• For Japan STED: Ensure Japanese language documentation and compliance with PMDA-specific requirements

International Trends and the Future of Technical Documentation

In recent years, international harmonization of medical device regulations has progressed, affecting STED and technical documentation requirements. Particularly noteworthy trends include:

Continued Evolution of IMDRF Guidance: IMDRF continues to update and promote the adoption of ToC guidance internationally. The shift from traditional STED to the more structured ToC format represents a significant advancement in harmonization efforts.

Medical Device Single Audit Program (MDSAP): Expansion of programs that can respond to regulatory requirements of multiple countries with a single audit. MDSAP participants include the United States, Canada, Australia, Brazil, and Japan.

Rise of IMDRF Table of Contents (ToC) Format: In some markets, the IMDRF ToC format is replacing STED. Additionally, CSDT (Common Submission Dossier Template) is adopted in ASEAN countries.

Utilization of Real-World Data: Growing importance of continuous STED/documentation updates through the utilization of post-market data. Regulatory authorities increasingly expect post-market surveillance data to be integrated into technical documentation throughout the product lifecycle.

Response to Digital Health Devices: Development of specific requirements for medical devices utilizing AI and software. Recent significant developments include:

2025 IMDRF AI/ML Guidance

In January 2025, IMDRF released two critical guidance documents that significantly impact the regulation of AI-enabled medical devices:

IMDRF/AIML WG/N88 FINAL:2025 – Good Machine Learning Practice (GMLP) Principles: This guidance establishes 10 principles for good machine learning practice in medical device development. These principles are aligned with requirements from the U.S. FDA, Health Canada, and the UK MHRA, and cover:

• Data management and quality
• Model development and training
• Clinical evaluation of AI/ML-enabled devices
• Risk management specific to machine learning
• Transparency and documentation requirements

IMDRF/SaMD WG/N81 FINAL:2025 – Characterization Considerations for Medical Device Software and Software-Specific Risk: Building on the risk categorization framework established in IMDRF/SaMD WG/N12 FINAL:2014, this document:

• Expands the scope to include all medical device software (MDSW), including embedded software (Software in a Medical Device – SiMD)
• Aligns with EU MDR/IVDR terminology of “medical device software”
• Provides comprehensive guidance on characterizing MDSW and assessing software-specific risks
• Emphasizes the importance of clear intended purpose statements for risk assessment

These guidance documents are already influencing regulatory expectations globally and manufacturers developing AI/ML-enabled devices should incorporate these principles into their technical documentation.

Electronic Submission Evolution: Many regulatory authorities are moving toward electronic submission systems. For example:

• Japan PMDA is implementing eCTD v4.0 with enhanced metadata and validation requirements
• Electronic submission facilitates more efficient document management and review processes
• Cloud-based regulatory management systems are becoming standard practice

Comparison of Technical Documentation Formats

To help manufacturers understand the different requirements across major markets, the following table compares key aspects of various technical documentation formats:

Aspect	Traditional STED (GHTF)	IMDRF ToC	EU MDR/IVDR	ASEAN CSDT	Japan STED
Current Status	Largely replaced globally	Adopted by many major markets	EU-specific requirements	ASEAN-specific format	Still in use
Structure	~6 main sections	150+ chapters/sub-chapters	Annex II/III requirements	Similar to ToC with different numbering	STED-based with Japanese requirements
Flexibility	Limited	Matrix system (R/CR/NR/O)	Fixed requirements by class	Moderate	Class-based requirements
Language	Various	English (typically)	Multiple EU languages	English	Japanese mandatory
QMS Integration	Basic requirements	Detailed QMS information	Extensive QMS documentation	Moderate QMS requirements	ISO 13485 certification required
UDI Requirements	Not included	Fully integrated	Comprehensive UDI system	Basic UDI	Basic UDI implementation
Software Requirements	General guidance	Detailed software chapters	Software-specific requirements	General guidance	Software documentation per class
Post-Market Surveillance	Basic requirements	Detailed PMS expectations	Extensive PMCP requirements	Moderate PMS requirements	Re-examination system (4-10 years)
Electronic Submission	Not specified	Supports HL7 environment	eSubmission available	Varies by country	eCTD v4.0 in progress

Key Observations:

• The IMDRF ToC format offers the most comprehensive and flexible structure, allowing regulators to specify exactly which sections are required for different submission types
• EU MDR/IVDR maintains its own specific requirements but aligns conceptually with international principles
• Japan’s continued use of STED format reflects its gradual approach to regulatory harmonization while maintaining effective oversight
• Manufacturers pursuing global market access should consider developing a master technical documentation file that can be adapted to different formats

Practical Strategies for Global Market Access

For manufacturers seeking to market devices globally, strategic approaches to technical documentation include:

Master File Approach: Develop a comprehensive master technical documentation file containing all possible information that can be tailored to specific market requirements. This master file should:

• Follow the most comprehensive format (typically IMDRF ToC)
• Include all possible documentation elements
• Maintain a modular structure for easy adaptation
• Track all versions and updates systematically

Market-Specific Adaptation: Create market-specific submissions by:

• Identifying format requirements early in the development process
• Mapping master file content to local requirements
• Translating only necessary sections
• Ensuring compliance with local standards and regulations

Early Regulatory Consultation: Engage with regulatory authorities through:

• Pre-submission meetings (FDA, PMDA consultation systems)
• Notified Body engagement (for EU)
• Conformity assessment body consultations (for other markets)
• Participation in regulatory science initiatives

Continuous Update System: Establish processes for:

• Monitoring regulatory changes across target markets
• Updating master technical documentation regularly
• Managing change notifications in different jurisdictions
• Coordinating post-market surveillance data across markets

Summary

STED and technical documentation are not merely regulatory documents but important tools for ensuring the safety and effectiveness of medical devices. Properly prepared technical documentation not only streamlines the review process but also contributes to product quality improvement.

Medical device developers and application staff must understand the perspective of regulatory authorities and present necessary technical information logically and clearly. It is also required to pay attention to international regulatory trends and adapt to changes in requirements for technical documentation formats.

Current State and Future Direction:

• While the term “STED” continues to be used in some markets, particularly Japan, the global trend is toward more structured formats like the IMDRF ToC
• Manufacturers should understand which format each target market requires and develop strategies accordingly
• The increasing complexity of medical devices, particularly AI/ML-enabled devices, necessitates more comprehensive and detailed technical documentation
• International harmonization efforts continue, but complete uniformity across all markets remains a long-term goal

For companies aiming for global expansion of medical devices, strategic creation of technical documentation can be said to be a key element for market access. Understanding the evolving landscape of technical documentation requirements, from traditional STED to modern ToC formats and market-specific requirements, is essential for successful global regulatory strategy.

The recent release of IMDRF guidance on AI/ML devices (N88 and N81) represents the type of ongoing evolution in technical documentation requirements. Manufacturers must remain vigilant and adaptive, continuously monitoring regulatory developments and updating their documentation practices to maintain compliance and competitive advantage in the global medical device market.