[Company Name]

[Company Group, Division, Location]

Document Title: Preparation of a Technical File
Document Number:
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COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name]
[Company Group, Division, Location]

Preparation of a Technical File

[Document Number]
Rev x.xx DD/MM/YY

Table Of Contents
Table Of Contents..................................................................................................................................................1
1.0 Purpose..............................................................................................................................................................2
2.0 Scope.................................................................................................................................................................2
3.0 Definition Of Terms..........................................................................................................................................2
3.1 Design History File (DHF).....................................................................................................................2
3.2 Device Master Record (DMR)...............................................................................................................2
3.3 Medicinal Product..................................................................................................................................2
3.4 Technical File.........................................................................................................................................2
4.0 References.........................................................................................................................................................2
5.0 Responsibilities and Requirements...................................................................................................................2
6.0 Procedure and Contents.....................................................................................................................................2
6.1 Technical File Format............................................................................................................................2
6.2 Preparation of Technical File.................................................................................................................2
6.3 Technical File Contents..........................................................................................................................3
6.3.1 Declaration of Conformity.......................................................................................................3
6.3.2 General Description..................................................................................................................3
6.3.3 Design Specifications...............................................................................................................3
6.3.4 Essential Requirements............................................................................................................3
6.3.5 Results of Risk Analysis...........................................................................................................3
6.3.6 Techniques to Control and Verify the Design and Processes..................................................3
6.3.7 Connections to Other Devices..................................................................................................3
6.3.8 Use of Medicinal Product.........................................................................................................3
6.3.9 Integration of a Medicinal Product into the Device................................................................3
6.3.10 Clinical Data...........................................................................................................................3
6.3.11 Device Labeling......................................................................................................................3
6.3.12 Instructions for Use................................................................................................................4
6.3.13 Sterilization Processes and Procedures..................................................................................4
6.3.14 Purchasing Procedures............................................................................................................4
6.3.15 Product Identification Procedures During Manufacture........................................................4
6.3.16 Tests and Frequency Before Manufacture.............................................................................4
6.3.17 Tests and Frequency During Manufacture.............................................................................4
6.3.18 Tests and Frequency After Manufacture................................................................................4
6.3.19 Test Equipment.......................................................................................................................4
6.3.20 Test Equipment Calibration Records.....................................................................................4
6.3.21 Design Dossier (Class III Medical Device Only)..................................................................4
6.3.22 Design Examination Certificate (Class III Medical Device Only).......................................4
6.4 Review of the Technical File.................................................................................................................4
6.5 Documenting the Technical File............................................................................................................4

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COMPANY PROPRIETARY AND CONFIDENTIAL

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[Company Name]
[Company Group, Division, Location]

Preparation of a Technical File

[Document Number]
Rev x.xx DD/MM/YY

1.0

Purpose
This document defines the contents of and procedures for creating a Technical File in accordance with
Annex I (Essential Requirements) and Annex H (Declaration of Conformity) of the Medical Devices
Directive, 93/42/EEC.

2.0

Scope
This procedure applies to all product development programs for medical devices funded and managed
by [Company Name].

3.0

Definition Of Terms
3.1

Design History File (DHF)

A compilation of records that describes the design history of a finished product.

3.2

Device Master Record (DMR)

A compilation of records containing the procedures and specifications for a finished product.

3.3

Medicinal Product
Any substance or combination of substances presented for treating or preventing disease in
human beings or animals. Likewise considered a medicinal product is any substance or
combination of substances that may be administered to human beings or animals with a view to
making a medical diagnosis or to restoring, correcting, or modifying physiological functions in
human beings or in animals.

3.4

Technical File
A compilation of documents and technical files demonstrating development of a product in
accordance with the ISO-9001 International Standard, Section 4.4 (Design Control), and
compliance to the "essential requirements" set forth in the Medical Devices Directive,
93/421EEC, Annex I.

4.0

References
Medical Devices Directive (MDD), 93/421EEC
The Product Development Cycle
Design History File

5.0

Responsibilities and Requirements

[Insert the roles and responsibilities for the various positions that are involved with the preparation of a
technical file. Such positions as: the Business Management Team, Program Manager, Quality Systems
Manager, Technical Advisory Team, etc.]

6.0

Procedure and Contents

[Insert the procedures and policies associated with preparing a technical file. Include:
A description of the Technical File Format; it describes the product information and
documentation requirements. It is advised to use the technical file checklist to verify that all
appropriate information is included in the technical file. State on each item of the checklist
whether the item is applicable or not applicable.
6.1

Technical File Format

Use the approved Technical File Checklist to compile the Technical File. The checklist provides
a process to verify that the required documentation is compiled in the Technical File. This
procedure describes the product information and documentation requirements listed on the
checklist. If it is applicable to this product, cite the document (file name, number, etc.)
demonstrating compliance with the requirement and its location.

6.2

Preparation of Technical File

[Insert information that should be compiled on the technical file checklist, such as:

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COMPANY PROPRIETARY AND CONFIDENTIAL

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[Company Name]
[Company Group, Division, Location]

Preparation of a Technical File

[Document Number]
Rev x.xx DD/MM/YY

Device Name, Classification

Name of the File and location, letter of revision, the name of the individual compiling
the checklist, date.
Also include the person who compiles the checklist and the technical file along with those that
contributed input or information].
6.3

Technical File Contents

6.3.1
Declaration of Conformity
Provide the completed Declaration of Conformity in accordance with Annex H (Full
Quality Assurance System) of the Medical Devices Directive. The Quality Systems
Manager is responsible for preparing the Declaration of Conformity.
6.3.2
General Description
Provide document(s) giving a general description of the medical device including
method of operation, intended use, and other details generally describing the product
and its intended use. Also provide descriptive information related to any variants of the
product.
6.3.3
Design Specifications
Provide the Design Requirements Document and system, subsystem, and critical
component specification documents.
6.3.4
Essential Requirements
Provide the completed Essential Requirements Checklist for this medical device and
any required supporting documentation. See the applicable harmonized standards
contain technical details of the Essential Requirements.
6.3.5
Results of Risk Analysis
Provide completed technical report(s) and other documentation detailing results of risk
analysis for this medical device.
6.3.6
Techniques to Control and Verify the Design and Processes
Provide the Standard Operating Procedures related to design control in accordance with
section 4.4 of the ISO-9001 standards.
6.3.7
Connections to Other Devices
If the medical device must be connected to another device in order to perform its
intended use, provide the completed Essential Requirements Checklist for this device
combination and any required supporting documentation.
6.3.8
Use of Medicinal Product
If applicable, provide a statement that the device incorporates a medicinal product as an
integral part of its operation. Describe the medicinal product and application in the use
of this device.
6.3.9
Integration of a Medicinal Product into the Device
Provide test data validating the integration of a medicinal product into the device.
6.3.10
Clinical Data
Provide the data and results of the clinical trial to validate the medical device and its
intended use in accordance with Annex X of the Medical Devices Directive.
6.3.11
Device Labeling
Provide all documentation related to the labeling of the medical device including
packaging, labels, manuals, etc.

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COMPANY PROPRIETARY AND CONFIDENTIAL

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[Company Name]
[Company Group, Division, Location]

Preparation of a Technical File

[Document Number]
Rev x.xx DD/MM/YY

6.3.12
Instructions for Use
Provide the user's instructional manual and any other instructional manuals packaged
with medical device.
6.3.13
Sterilization Processes and Procedures
Provide documentation describing the processes and procedures for sterilizing the
medical device before packaging, shipment, and/or use.
6.3.14
Purchasing Procedures
Provide documentation describing procedures for purchasing components to
manufacture the medical device.
6.3.15
Product Identification Procedures During Manufacture
Provide documentation describing procedures for identifying, tracking, and controlling
the product through the manufacturing process.
6.3.16
Tests and Frequency Before Manufacture
Provide documentation describing procedures for verifying conformance and quality of
components and subsystems before manufacturing the device.
6.3.17
Tests and Frequency During Manufacture
Provide documentation describing procedures for verifying conformance and quality
while manufacturing the device, including frequency of tests.
6.3.18
Tests and Frequency After Manufacture
Provide documentation describing procedures for verifying conformance and quality
after the device is manufactured, including frequency of tests.
6.3.19
Test Equipment
Provide documentation describing the equipment used for the above tests.
6.3.20
Test Equipment Calibration Records
Provide documentation describing calibration of the test equipment.
6.3.21
Design Dossier (Class III Medical Device Only)
Prepare a Design Dossier in accordance with the Medical Devices Directive. The
Design Dossier is the Technical File plus the Device Master Record for that product.
6.3.22
Design Examination Certificate (Class III Medical Device Only)
The notified body prepares the Design Examination Certificate after review of the
Technical File.
6.4

Review of the Technical File

[Specify who will be reviewing the technical file before it is submitted. Discuss the role and
responsibility of the individuals that are reviewing and submitting the file.

6.5

Documenting the Technical File

[Specify who documents the technical file and the checklist and where it will be stored].

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COMPANY PROPRIETARY AND CONFIDENTIAL

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