Technical Documentation

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices (STED):

STED ¹ is a document format and template developed by the Global Harmonisation Task Force (GHTF), which has since been succeeded by the International Medical Device Regulators Forum (IMDRF). The STED template is intended to help medical device manufacturers provide a comprehensive summary of technical information necessary to demonstrate conformity with the essential principles of safety and performance. The STED document typically includes information on the following:

• Device Description: A detailed description of the IVD device, its intended use, and its components.
• Design and Manufacturing Information: Documentation related to the device’s design, development, and manufacturing processes, including risk management and validation activities.
• Performance Evaluation: Data from performance evaluation studies and clinical performance data to support the device’s intended use and claims.
• Analytical Performance: Information on the device’s analytical performance characteristics, including sensitivity, specificity, and accuracy.
• Clinical Performance: Clinical evidence demonstrating the device’s safety and effectiveness for its intended use.
• Labelling and Instructions for Use: Details of the device’s labelling, instructions for use, and other associated documentation. STED is designed to streamline the regulatory review process by providing a standardised format for technical documentation, making it easier for regulatory authorities to assess the safety and performance of IVD devices. STED is recognised in the U.S., Europe, Canada, Australia and Japan.

Common Submission Dossier Template (CSDT):

CSDT is a standardised format for the submission of regulatory information for medical devices in ASEAN countries. It was developed by the Association of Southeast Asian Nations (ASEAN) Medical Device Product Working Group (MDPWG) to facilitate the registration and approval process for medical devices in the region. The CSDT is designed to streamline the regulatory submission process and ensure consistency in the documentation required by ASEAN member countries. It provides a common structure for presenting technical information about medical devices, making it easier for regulatory authorities to review and assess the safety and performance of the products. Key features of the Common Submission Dossier Template (CSDT) may include:

• Table of Contents: An organised and standardised table of contents that outlines the sections and subsections of the submission dossier.
• Administrative Information: Details about the manufacturer, applicant, and authorised representative, if applicable, along with information about the medical device and its intended use.
• Device Description and Technical Specifications: Comprehensive information about the medical device, including its design, materials, components, and specifications.
• Quality Management System (QMS): Documentation related to the manufacturer’s quality management system, such as ISO 13485 certification and quality control processes.
• Essential Principles of Safety and Performance: Evidence demonstrating how the medical device meets the essential principles of safety and performance set by ASEAN member countries.
• Performance Evaluation: Clinical and non-clinical data supporting the safety and performance of the medical device, including verification and validation studies.
• Labelling and Instructions for Use: Detailed labelling information and instructions for the end-users, ensuring the safe and proper use of the device.
• Post-Market Surveillance (PMS): Plans for post-market surveillance activities, including methods for monitoring device performance and handling adverse events.
• Regulatory Status in Other Markets: Information on the device’s regulatory status in other countries or regions, if applicable.

To meet USFDA requirements, further consideration of the technical documentation structure is necessary to provide:

• Device Master Record (DMR): a comprehensive collection of documents and records describing the medical device’s design, manufacturing, and quality control processes. It includes specifications, drawings, procedures, and any other information necessary to ensure consistent production and compliance with regulations.
• Design History File (DHF): containing all documentation related to the design and development of the medical device. It includes design inputs, outputs, verification, validation, risk analysis, and design changes.
• Device History Record (DHR), confirming that the device is produced according to the specifications in the DMR The device classification may also influence the content and structure of the technical documentation as the requirements differ between 510(k) and premarket approval (PMA) submissions. For high-risk medical devices, a PMA application is required and contains extensive evidence of safety and effectiveness based on clinical data and scientific evidence.

ISO 13485:2016 also requires a technical documentation format, the “medical device file”, to be compiled and maintained for each product, including information such as:

• Description of the device

• Intended purpose

• Labelling (packaging, IFU, direct marking, installation maintenance instructions as applicable)

• Device specification (design, specifications for manufacturing, packaging, storage and transport)

• Proof of conformity (design verification and validation)

• Market surveillance

MedDev Central Academy:

• MedDev 101: Medical technology orientation training

MedDev Central Knowledge Hub:

• Medical Device Regulations
• Quality Management Systems (QMS)
• Medical Device Glossary

European Union (EU):

European Association of Medical Device Notified Bodies offers non-binding guidance from 2010: Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation

European Union (EU):

Medical Devices Regulation (MDR) 2017/745:

• Technical Documentation Requirements: Chapter I, Article 10(4) and ANNEX II and III

In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746

• Technical Documentation Requirements: Chapter I, Article 10(4) and ANNEX II and III

United States of America (USA):

Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):

• Technical documentation requirements are specified in the QMS requirements PART 820 Quality System Regulation Procedures

ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes, Section 4.2.3

510(k) Clearance: A premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA (Premarket Approval).

CE Marking: A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).

Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.

Common Submission Dossier Template (CSDT): A standardised format for the submission of regulatory information for medical devices in ASEAN countries.

Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.

Design History File (DHF): A compilation of records that describes the design history of a finished device.

Device Master Record (DMR): A comprehensive collection of documents and records describing the medical device’s design, manufacturing, and quality control processes.

Device History Record (DHR): Report confirming that the device is produced according to the specifications in the DMR

FDA Approval: The process by which the U.S. Food and Drug Administration (FDA) officially recognises that a medical device is safe and effective for its intended use.

Harmonisation: The process of aligning standards, requirements, and procedures across different jurisdictions to ensure consistent safety and efficacy evaluations and market access for medical devices.

International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).

ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.

Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)

Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.

Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.

Pre-market Approval (PMA): The process by which the U.S. FDA evaluates and approves the safety and effectiveness of high-risk medical devices before they can be marketed and sold in the United States.

Quality Assurance (QA): The systematic activities implemented to ensure that devices consistently meet regulatory requirements and standards while meeting user needs and expectations.

Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.

Record: A documented piece of evidence detailing activities, decisions, or results, created and maintained to demonstrate compliance with regulatory requirements and quality management standards.

Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.

Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.

Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.

Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.

Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.

Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.

Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices (STED): A document format and template developed by the Global Harmonization Task Force (GHTF)

Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.

Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.