Sample CE Technical File For Product CE Mark Certification- Complete Documentation Kit

The contents of the CE – Conformity to European Mark document kit which we offer includes more than 45 document files as listed below:

1. Sample CE technical file (helpful for Machine, Pressure, EMC, LVD, Medical device and other industry)
2. Product descriptions, sample process details, product validation reports,
3. Procedures
4. sample forms and records.

Note: The sample CE technical file provided by us is a sample and the company needs to make its own technical file after considering its own system, as well as applicable directives and product and necessary samples, are given in the CE technical file for CE certification.

Index of CE Technical File

1. Title of each chapter
2. Scope of Products under CE Certifications
3. Company Profile
4. Quality Control and Manufacturing Facilities
5. Manufacturing Flow chart
6. Product Descriptions -Technical Specification
7. Bill of materials
8. Product Drawings
9. Product Test Reports
10. Product Validation Records
11. Procedure for controlled environment conduct (with contamination control
12. Procedure for facility maintenance
13. Procedure for equipment operations and maintenance
14. Procedure for batch records
15. Procedure for Identification and Traceability
16. Process for Handling, storages Packaging, Preservation and Delivery
17. Procedure for final product release
18. Procedure for receiving an inspection
19. Process for deviation
20. Procedure for retaining samples
21. Procedure for stability studies
22. Process for product recall
23. Procedure for post-market surveillance
24. Process for Validation
25. Procedure for labeling
26. Procedure for CE Marking
27. Procedure for risk analysis
28. Procedure for Failure mode effective control analysis
29. Procedure for product classification and conformity root (Only sterile products)
30. The procedure of Handling of Non-conformities
31. Risk analysis
32. Materials specifications for various products
33. Quality Plan
34. Cleaning validation (Plan & Report)
35. Sealing validation (Plan & Report)
36. ETO validation (Plan & Report)
37. Packaging qualification (Plan & Report)
38. Reports of bio burden
39. Reports of sterility. Acute toxicity and pyrogen
40. Test reports from external laboratories
41. Product applications
42. Products labels
43. Use instructions
44. Declaration of conformity
45. List of Harmonized Standards
46. Essential safety requirements

Our sample product technical file for CE Mark can be used for the preparation of technical file for any kind of industry after providing necessary details of your company and your products and necessary changes done with the guidelines given in this model technical file.

Documentation package:

Our documentation kit (Technical file) contains sample documents required for CE certification as listed below. All documents are in MS Word files and you can edit them. You can make changes as per your organization’s need and within few days your entire Technical File with all necessary controls will be ready. In the Technical File, documented information (processes described in individual file, etc.) are required a few places only. But for making the system better, we have provided many editable templates from which a user can select templates as per their own requirement and make some minor changes in them to make own system. Two types of documented information are provided in this kit, as listed below:
1. Maintain documented information (Technical File with individual processes etc.)
2. Retain documented information (Forms / Templates)
Under the main directories, further files are provided in MS Word document as per the details given below.

1. Technical File (46 Different processes as required in CE Mark Technical File):

It is a comprehensive technical file, which can be used by any type of products. User has to just check the applicability of relevant documents, requirements of relevant directives and then can modify to suit the product under the certification. The content of the comprehensive technical file are given on the next page;
(A) Table of Contents – Technical File

1. Index 2
2. Scope of Products under CE Certifications 1
3. Company Profile 1
4. Quality Control and Manufacturing Facilities 3
5. Manufacturing Flow chart 1
6. Product Descriptions –Technical Specification 1
7. Bill of materials 1
8. Product Drawings 1
9. Product Test Reports 2
10. Product Validation Records 1
11. Procedure for controlled environment conduct (with contamination control 1
12. Procedure for facility maintenance 1
13. Procedure for equipment operations and maintenance 1
14. Procedure for batch records 1
15. Procedure for Identification and Traceability 2
16. Process for Handling, storages Packaging, Preservation and Delivery 2
17. Procedure for final product release 1
18. Procedure for receiving inspection 1
19. Process for deviation 1
20. Procedure for retain samples 1
21. Procedure for stability studies 1
22. Process for product recall 1
23. Procedure for post market surveillance 2
24. Process for Validation 2
25. Procedure for labeling 1
26. Procedure for CE Marking 2
27. Procedure for risk analysis 2
28. Procedure for Failure mode effective control analysis 3
29. Procedure for product classification and conformity root (Only sterile products) 2
30. Procedure of Handling of Non–conformities 2
31. Risk analysis 2
32. Materials specifications for various products 1
33. Quality Plan 2
34. Cleaning validation (Plan & Report) 2
35. Sealing validation (Plan & Report) 2
36. ETO validation (Plan & Report) 2
37. Packaging qualification (Plan & Report) 1
38. Reports of bio burden 1
39. Reports of sterility. Acute toxicity and pyrogen 1
40. Test reports from external laboratories 1
41. Product applications 1
42. Products labels 1
43. Use instructions 1
44. Declaration of conformity 1
45. List of Harmonized Standards 1
46. Essential safety requirements 1

The content with the red fonts are applicable of product falls under Medical Device Directives only.

2. Blank sample formats for all the departments (23 sample formats)

This directory includes sample copy of blank forms that are required to maintain records as well as establish control and create system in the organization to comply with the requirements of CE Mark. The samples are given for the users as a guide to follow. The organization is free to change the same to suit their own requirements. The blank formats can be used as templates. A total of 23 blank formats are provided as per the list given below.

List of blank formats

1. Calibration Status of Instrument / Equipment
2. Master List of Records
3. Audit Non–Conformity Report
4. Corrective Action Report
5. Preventive Action Report
6. Production Plan
7. Job Card
8. Disposal of Non–Conforming Products
9. List of Equipments
10. List of Instrument
11. Customer Feed Back Form
12. Customer Complaint Report
13. Breakdown History Card
14. Preventive Maintenance Schedule
15. Equipment wise Preventive Maintenance Check Points (Total 8 different checkpoints)
16. Final Inspection Report
17. Risk Analysis
18. Installation And Commissioning Report
19. Service Report
20. Bill of Materials
21. Preservation Assessment
22. Sample Declaration of Conformity–1
23. Sample Declaration of Conformity–2