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TECHNICAL DOCUMENTATION

2018-08-01 V1

1. What is technical file?2. USA 510k Format3. EU (MDD/MDR)4. Japan TF5. Korean TF6. ASEAN CSDT7. Differences between FDA

510k and EU TF8. Essential Elements9. Design History File10.Essential

Principles/Essential Requirements

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10.Risk Management11.Performance Verification12.Safety Verification13.Post Market Surveillance14.Post Market Clinical

Follow Up15.Clinical Evaluation /

Clinical Investigation16.MDR17.General Safety and

Performance Requirements (MDR)

EU – A Technical File is a documentation demonstrating compliance to the essential safety and health requirements set down by the relevant Directive(s). It includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device.

US – No precise requirements; it mostly refers to the 510k submission file

Other countries: No clear definition but mostly means submission file like US

GHTF/IMDRF: Summary Technical Documentation (STED)

ASEAN: Common Submission Dossier Template (CSDT)3

1. Name of Manufacturer2. Quality System Information of Manufacturer3. Device Summary4. Classification and Applied Rules5. List of Applicable Standards and Guidelines

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1. Detailed Product Information2. Essential Requirements3. Risk Analysis4. Product and Quality Assurance5. Sterilization Aseptic Filling6. Documentation of Quality System 7. Packaging Qualification, Shelf Life

and Logistics8. Product Labeling, Instruction for Use9. Technical and Mechanical

Investigation

10. Microbiological Investigation11. Preclinical Investigation12. Device Incorporating Medical

Substance13. Device Incorporating Non-Viable

Materials of Animal Origin14. Device Incorporating Phthalates15. Device with Measuring Function16. Clinical Evaluation

Part B

Part A

1. Medical Device User Fee Cover Sheet (Form FDA 3601)

2. CDRH Premarket Review Submission Cover Sheet

3. 510(k) Cover Letter4. Indications for Use Statement5. 510(k) Summary or 510(k)

Statement6. Truthful and Accuracy

Statement7. Class III Summary and

Certification8. Financial Certification9. DOC and Summary Reports

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10. Executive Summary11. Device Description12. Substantial Equivalence

Discussion13. Proposed Labeling14. Sterilization and Shelf Life15. Biocompatibility16. Software17. EMC and Electrical Safety18. Performance Testing - Bench19. Performance Testing - Animal20. Performance Testing - Clinical

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1. Category2. Name3. Purpose of Use, Efficacy4. Shape, Structure or

Principle5. Raw Materials or

Components6. Specifications7. Operation for use /

Procedure8. Manufacturing Process9. Storage10. Site for Manufacturing11. Manufacturing site for Raw

Material12. Remarks, Package Insert

Attachments

A. Origin or history until discovery / regulatory status in foreign countries

B. Reason / background for Specification

C. Stability & EnduranceD. Document for compatibility

with Essential PrincipleE. PerformanceF. Risk AnalysisG. Manufacturing (Process,

Sterilization)H. Clinical Data

1. Intended use2. Operation Principle3. Electrical/Mechanical Safety4. Biological Safety5. Sterility Data6. Radiation Safety7. EMC8. Performance Data9. Physical/Chemical Characteristics10. Stability Data11. Clinical Evaluation12. Origin or grounds for discovery and development13. Uses in other countries

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1. Relevant Essential Principles and Method Used to Demonstrate Conformity

2. Device Description

3. Summary of Design Verification and Validation Documents

4. Device Labelling

5. Risk Analysis

6. Manufacturer Information

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DESIGN HISTORY FILE

ESSENTIALPRINCIPLES

PERFORMANCEVERIFICATION

SAFETY VERIFICATION

RISKMANAGEMENT

POST MARKETSURVEILLANCE

CLINICALEVALUATION

DHF contains all of the product development documentation pertaining to a finished medical device PROJECT PROPOSAL

DESIGN PLANNING

DESIGN INPUT EVALUATION

DESIGN OUTPUT EVALUATION

DESIGN VERIFICATION/VALIDATION EVALUATION (IOVVMATRIX)

DESIGN TRANSFER

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DESIGN HISTORY FILE

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ESSENTIALPRINCIPLES

Essential performance is the performance necessary to achieve freedom from unacceptable risk.

To determine this, the manufacturer must consider the device performance functions and evaluate the presence of acceptable and unacceptable risk.

An unacceptable risk leads to a performance function being classified as essential performance.

Collection of performance testing or validation reports

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PERFORMANCEVERIFICATION

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SAFETY VERIFICATION

According to 21 CFR 860.7(d)(1), it is defined as: There is reasonable assurance that a device is

safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks

Collection of safety validation / test report

SCOPE PRODUCT DESIGN

PRODUCTION PROCESS

USER ERROR

DOCUMENTATION RM PLAN

RM REPORT

FMEA

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RISKMANAGEMENT

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CLINICALEVALUATION

A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation of your medical device.

A CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices. The CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk.

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POST MARKETSURVEILLANCE

PMS requires: 1. that the manufacturer institute and maintain an

up-to-date systematic procedure to review experience gained from devices in the post-production phase, which include provisions referred to in Annex X (93/42/EEC), or Annex VII (90/385/EEC) and;

2. the implementation of appropriate means to apply any necessary corrective action

Documentation PMS Plan PMS Report

Annex II – Technical Documentation1. Device description and specification, including

variants and accessories DEVICE DESCRIPTION AND SPECIFICATION REFERENCE TO PREVIOUS AND SIMILAR GENERATIONS OF DEVICE

2. Information to be supplied by the manufacturer3. Design and manufacturing information4. General safety and performance requirements5. Benefit-risk analysis and risk management6. Product verification and validation PRE-CLINICAL AND CLINICAL DATA ADDITIONAL INFORMATION REQUIRED IN SPECIFIC AREAS

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Annex III –Technical Documentation on Post Market Surveillance1. The post-market surveillance plan2. The PSUR (Periodic Safety Update Report)3. PMS Report

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SPR 1: Performance and safetySPR 2: Reduction of risksSPR 3: Risk management systemSPR 4: Risk control measures and residual risksSPR 5: Risks related to useSPR 6: Device lifetimeSPR 7: Packaging, transport, storageSPR 8: Risk-benefit ratioSPR 9: Devices without a medical purposeSPR 10: Chemical, physical and biological properties

SPR 10.1: GENERAL CONSIDERATIONS FOR MATERIALSSPR 10.2: RISKS FROM CONTAMINANTS AND RESIDUESSPR 10.3: COMPATIBILITY WITH MATERIALS AND SUBSTANCESSPR 10.4: SUBSTANCES CONTAINED IN AND RELEASED FROM THE DEVICESPR 10.5: RISK OF UNINTENTIONAL INGRESSSPR 10.6: RISKS RELATED TO PARTICLE SIZE

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SPR 11: Infection and microbial contaminationSPR 11.1: RISK OF INFECTIONSPR 11.2: DESIGN FOR REUSESPR 11.3: DEVICES WITH A SPECIFIC MICROBIAL STATESPR 11.4: DEVICES DELIVERED STERILESPR 11.5: VALIDATION FOR STERILE DEVICESSPR 11.6: ENVIRONMENTAL CONTROLSPR 11.7: PACKAGING FOR NON-STERILE DEVICESSPR 11.8: LABELLING FOR STERILE STATE

SPR 12: Devices incorporating a medicinal product; substances absorbed or locally dispersed

SPR 12.1: Devices incorporating a medicinal productSPR 12.2: Devices composed of substances absorbed or locally dispersed

SPR 13: Devices incorporating materials of biological originSPR 13.1: Tissues, cells or derivatives of human originSPR 13.2: Tissues, cells or derivatives of animal originSPR 13.3: Other non-viable biological substances

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SPR 14: Construction of devices and interaction with their environmentSPR 14.1: Use in combinationSPR 14.2: Risks of interaction with the environmentSPR 14.3: Risks of fire or explosionSPR 14.4: Design for adjustment, calibration and maintenanceSPR 14.5: Design for compatibilitySPR 14.6: Measurement, monitoring or display scalesSPR 14.7: Design and manufacture for safe disposal

SPR 15: Devices with a diagnostic or measuring functionSPR 16: Protection against radiationSPR 17: Electronic programmable systems and softwareSPR 18: Active devices and devices connected to themSPR 19: Particular requirements for active implantable devices

SPR 19.1: Particular risks to be reduced for active implantable devicesSPR 19.2: Device compatibility and reliability of energySPR 19.3: Identification of devices and componentsSPR 19.4: Identification code

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SPR 20: Protection against mechanical and thermal risks SPR 21: Protection against the risks posed to the patient or user by devices

supplying energy or substancesSPR 22: Protection against the risks posed by medical devices intended by

the manufacturer for use by lay personsSPR 23: Label and instructions for use

SPR 23.1: General requirements for information supplied by the manufacturerSPR 23.2: Label requirementsSPR 23.3: Sterile package label requirementsSPR 23.4: Instructions for Use

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