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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 |
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 |