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Medical Device Technical File (MDR)

MDR 2017 / 745 Annex II Medical Device Technical File is a summary document prepared by the manufacturer in a clear, well-organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the device in question.

 

The Medical Device Technical  File must be submitted to Notified Body or Competent Authority for review and approval. The Technical File should be preferably made in the English language or in an official language of an EU member state.

 

The file must be available on request for the whole life cycle of the medical device (5 years for low risk and 16 years for high-risk devices). Non-EU manufacturers must keep the technical file with the authorized representative in the EU.

 

Irrespective of a device class, intended use, construction and or safe history of the device, the manufacturer must have and keep up-to-date technical documentation/technical file to demonstrates compliance with general safety and performance requirements Annex I of MDR 2017/745.

Criteria for the selection of MDR Technical File(s)

QA and Regulatory team members are always confused or find it difficult in identifying the required number of technical files for the products planned for European CE Marking.

 

It is advised to remember that medical device technical file or technical documentation is all about your device to establish safety and performance.

 

It means you cannot combine products with the different intended use, or different class, or different construction material, or even different design.

  • Device Intended use and Indication of use
  • Site of application
  • Design change or major constructional changes
  • State of the art

Consultant for Technical Documentation

You cannot call anyone a master at medical device technical file preparation. A group of professionals experienced in EU medical device CE Marking covering core technical areas such as risk analysis, validations, design, shelf-life, usability, biological evaluation, safety, chemical characteristics, and clinical evaluation is called experts and such a group of experts makes us a team called I3CGLOBAL.

  • Requirement & Identification as per CE MDR
  • Risk classification and identification of assessment route of CE Marking
  • Systematically organize and arrange Files and review.
  • Clinical Evaluation documentation covering PMS, PMCF & PSUR
  • Risk Analysis
  • Medical Device Quality Management System Implementation

A common type of Medical Device Technical File(s)

MDR has given specific requirements on what to include in your medical device technical file documentation. You can get more information from the below sections.

 

Depending upon the Device construction there are various types of Technical Files >>

MDR 2017/745 – ANNEX II TECHNICAL DOCUMENTATION

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

 

BUY TECHNICAL FILE TEMPLATES IN EDITABLE WORD FILES WITH GUIDANCE

  • Class I – Active Device, Non-Sterile with/without Software
  • Class I – Non-Active Device, Non-Sterile
  • Class I – Non-Active Device, Sterile / Measuring / Reusable
  • Class I – Active Device, Sterile / Measuring / Reusable
  • Class I – Software Device with or without Measuring Function
  • Class IIa – Active Device, Sterile / Non-Sterile / Measuring / Reusable /with / without Software
  • Class IIa – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable
  • Class IIa – Non-Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable
  • Class IIa – Software Device, with or without Measuring Function
  • Class IIb – Active Device, Sterile / Non-Sterile / Measuring / Reusable with/without Software
  • Class IIb – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable
  • Class IIb – Non-Active Device, Implant Sterile / Nonsterile / Measuring / Reusable
  • Class IIb – Software Device, with or without Measuring Function
  • Class III – Active Device, Sterile / Non-Sterile / Measuring / Reusable with/without Software
  • Class III – Non-Active Device, Sterile / Non-Sterile / Measuring / Reusable
  • Class III – Non-Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable
  • Class III – Active Device, Implant Sterile / Non-Sterile / Measuring / Reusable / with or without Software
  • Class III – Software Device, with or without Measuring Function
  • Special Rule – Class III – Devices incorporate medicinal product under rule 14
  • Special Rule – Class IIa/IIb – Devices for contraception under rule 15
  • Special Rule – Class IIa/IIb – Devices used for disinfecting, cleaning or sterilising medical device under rule 16
  • Special Rule  – Class III – Devices made using tissues or cells of human or animal origin, or their derivatives under rule 18
  • Special Rule – Class IIa/IIb/III – Nanomaterials under rule 19
  • Special Rule – Cass IIa/IIb – Devices for medicinal inhalation under rule 20
  • Special Rule – Class IIa/IIb/III – Devices composed of substances that are absorbed or locally dispersed under rule 21

 

Medical Device Technical File 1

IMPORTANT MDR TECHNICAL FILE RELATED PROCEDURES & TEMPLATES

  1. Procedure for Device Classification
  2. CE Marking Procedure
  3. Labelling Procedure
  4. Vigilance Procedure
  5. Significant Change Notification Procedure

 

Medical Device Technical File 2