MDR Technical File GAP Analysis

Medical Device Technical File

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. It should be preferably made in the English language or in an official language of an EU Member state. It 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 file with the European Authorized Representative.

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

Criteria for the selection of Technical File

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

It is advised to remember that medical device technical file 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 Medical Device Technical File

You cannot call anyone a master at medical device technical file preparation. We are 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. You can directly contact us for medical device technical file preparation.

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 Files

MDR has given specific requirements on what to include in your technical documentation. You can get more information from the below sections. Depending upon the Device construction there are various types of medical device technical file.

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

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IMPORTANT MDR TECHNICAL FILE RELATED PROCEDURES & TEMPLATES

Procedure for Device Classification
CE Marking Procedure
Labelling Procedure
Vigilance Procedure
Significant Change Notification Procedure