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MDR Technical File Table of Contents

MDR Technical File Table of Contents

Below explained new MDR technical file table of contents covering MDR 2017/745 ANNEX II requirements all clause and sub clause numbers for easy reference.

MDR ANNEX
II CLAUSES

SEC. NO.

DESCRIPTION

0
I
INTRODUCTION
0
1
TECHNICAL FILE DETAILS
0
1.1
REVISION HISTORY
0
1.2
WARNING
0
1.3
TECHNICAL FILE
0
1.4
PURPOSE
0
1.5
SCOPE
0
1.6
COMPANY PROFILE
0
1.7
LEGAL NAMES AND ADDRESS OF THE MANUFACTURER
0
1.8
EUROPEAN UNION AUTHORIZED REPRESENTATIVE
0
1.9
NOTIFIED BODY
II
TECHNICAL DOCUMENTATION
1
1
DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
1.1
1.1
DEVICE DESCRIPTION AND SPECIFICATION
1.1a
1.1.1
PRODUCT OR TRADE NAME
1.1a
1.1.2
GENERAL DESCRIPTION
1.1a
1.1.3
INTENDED PURPOSE
1.1a
1.1.4
INTENDED USERS
1.1b
1.1.5
BASIC UDI-DI
1.1c
1.1.6
THE INTENDED PATIENT POPULATION
1.1c
1.1.7
MEDICAL CONDITIONS
1.1c
1.1.8
INDICATIONS
1.1c
1.1.9
CONTRA-INDICATIONS
1.1c
1.1.10
WARNINGS
1.1d
1.1.11
PRINCIPLE OF OPERATION
1.1e
1.1.12
MEDICAL DEVICE RATIONALE
1.1f
1.1.13
DEVICE CLASSIFICATION AND JUSTIFICATION
1.1g
1.1.14
EXPLANATION OF NOVEL FEATURES
1.1h
1.1.15
DESCRIPTION OF THE ACCESSORIES
1.1i
1.1.16
DESCRIPTION OF THE VARIANTS
1.1j
1.1.17
COMPONENTS DESCRIPTION WITH DRAWINGS
1.1k
1.1.18
DESCRIPTION OF THE RAW MATERIALS
1.1l
1.1.19
TECHNICAL SPECIFICATIONS
1.2
1.2
REFERENCE TO PREVIOUS AND SIMILAR GENERATIONS OF THE DEVICE
1.2a
1.2.1
AN OVERVIEW OF THE PREVIOUS GENERATION
1.2b
1.2.2
AN OVERVIEW OF EQUIVALENT OR SIMILAR DEVICES
2
2
INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
2
2.1
LABELS
2
2.2
IFU
3
3
DESIGN AND MANUFACTURING INFORMATION
3a
3.1
DESCRIPTION OF THE DESIGN
3b
3.2
DESCRIPTION OF THE MANUFACTURING PROCESS
3b
3.2.1
MANUFACTURING PROCESSES
3b
3.2.2
FINAL PRODUCT SPECIFICATION AND TESTING
3b
3.2.3
MANUFACTURING ENVIRONMENTAL CONTROLS
3c
3.3
SUPPLIERS AND SUBCONTRACTORS
4
4
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
4
4.1
THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
4
4.2
DECLARATION OF CONFORMITY
4c, 4d
4.3
LIST OF APPLICABLE LEGISLATION
4c, 4d
4.4
LIST OF APPLICABLE GUIDELINES
4c, 4d
4.5
LIST OF APPLICABLE HARMONIZED STANDARDS
4c, 4d
4.6
LIST OF APPLICABLE NON- HARMONIZED STANDARDS
5
5
BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
5a
5.1
THE BENEFIT-RISK ANALYSIS
5b
5.2
RISK MANAGEMENT
6
6
PRODUCT VERIFICATION AND VALIDATION
6.1
6.1
PRE-CLINICAL AND CLINICAL DATA
6.1a
6.1.1
PRE-CLINICAL SAFETY
6.1b
6.1.2
BIOCOMPATIBILITY OF THE DEVICE
6.1b
6.1.3
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY
6.1b
6.1.4
SOFTWARE VERIFICATION AND VALIDATION
6.1b, 6.2e
6.1.5
STERILIZATION
6.1b
6.1.6
STABILITY
6.1c
6.1.7
CLINICAL EVALUATION
6.1d
6.1.8
POST MARKET ACTIVITIES
6.1d,6.2e
6.1.9
PACKAGING AND TRANSPORTATION
6.2
6.2
ADDITIONAL INFORMATION REQUIRED IN SPECIFIC CASES
6.2a
6.2.1
MEDICINAL PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2001/83/EC
6.2b
6.2.2
TISSUES OR CELLS OF ANIMAL ORIGIN
6.2c
6.2.3
DEVICES THAT ARE COMPOSED OF SUBSTANCES OR COMBINATIONS OF SUBSTANCES
6.2d
6.2.4
CMR OR ENDOCRINE-DISRUPTING ACTIVITY
6.2e
6.2.5
STERILIZATION
6.2f
6.2.6
MEASURING FUNCTION
6.2g
6.2.7
COMBINATION WITH OTHER DEVICES
0
6.2.8
  MANUFACTURER DECLARATION
0

III

CONCLUSION AND APPROVAL

 

Tags: MDR Technical File table of Contents; MDR Technical Documentation, MDR 2017/745