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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.
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MDR ANNEX |
SEC. NO. |
DESCRIPTION |
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0
|
I
|
INTRODUCTION |
|
0
|
1
|
TECHNICAL FILE DETAILS |
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0
|
1.1
|
REVISION HISTORY |
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0
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1.2
|
WARNING |
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0
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1.3
|
TECHNICAL FILE |
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0
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1.4
|
PURPOSE |
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0
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1.5
|
SCOPE |
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0
|
1.6
|
COMPANY PROFILE |
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0
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1.7
|
LEGAL NAMES AND ADDRESS OF THE MANUFACTURER |
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0
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1.8
|
EUROPEAN UNION AUTHORIZED REPRESENTATIVE |
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0
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1.9
|
NOTIFIED BODY |
|
II
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TECHNICAL DOCUMENTATION | |
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1
|
1
|
DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES |
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1.1
|
1.1
|
DEVICE DESCRIPTION AND SPECIFICATION |
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1.1a
|
1.1.1
|
PRODUCT OR TRADE NAME |
|
1.1a
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1.1.2
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GENERAL DESCRIPTION |
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1.1a
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1.1.3
|
INTENDED PURPOSE |
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1.1a
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1.1.4
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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
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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
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TECHNICAL SPECIFICATIONS |
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1.2
|
1.2
|
REFERENCE TO PREVIOUS AND SIMILAR GENERATIONS OF THE DEVICE |
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1.2a
|
1.2.1
|
AN OVERVIEW OF THE PREVIOUS GENERATION |
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1.2b
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1.2.2
|
AN OVERVIEW OF EQUIVALENT OR SIMILAR DEVICES |
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2
|
2
|
INFORMATION TO BE SUPPLIED BY THE MANUFACTURER |
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2
|
2.1
|
LABELS |
|
2
|
2.2
|
IFU |
|
3
|
3
|
DESIGN AND MANUFACTURING INFORMATION |
|
3a
|
3.1
|
DESCRIPTION OF THE DESIGN |
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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 |
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4
|
4.1
|
THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS |
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4
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4.2
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DECLARATION OF CONFORMITY |
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4c, 4d
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4.3
|
LIST OF APPLICABLE LEGISLATION |
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4c, 4d
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4.4
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LIST OF APPLICABLE GUIDELINES |
|
4c, 4d
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4.5
|
LIST OF APPLICABLE HARMONIZED STANDARDS |
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4c, 4d
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4.6
|
LIST OF APPLICABLE NON- HARMONIZED STANDARDS |
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5
|
5
|
BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT |
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5a
|
5.1
|
THE BENEFIT-RISK ANALYSIS |
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5b
|
5.2
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RISK MANAGEMENT |
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6
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6
|
PRODUCT VERIFICATION AND VALIDATION |
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6.1
|
6.1
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PRE-CLINICAL AND CLINICAL DATA |
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6.1a
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6.1.1
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PRE-CLINICAL SAFETY |
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6.1b
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6.1.2
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BIOCOMPATIBILITY OF THE DEVICE |
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6.1b
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6.1.3
|
ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY |
|
6.1b
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6.1.4
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SOFTWARE VERIFICATION AND VALIDATION |
|
6.1b, 6.2e
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6.1.5
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STERILIZATION |
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6.1b
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6.1.6
|
STABILITY |
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6.1c
|
6.1.7
|
CLINICAL EVALUATION |
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6.1d
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6.1.8
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POST MARKET ACTIVITIES |
|
6.1d,6.2e
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6.1.9
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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
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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 |