Written By: Adnan Ashfaq
Other references
Version: 001
NA
Date:
TECHNICAL FILE FOR CE MARKING MEDICAL DEVICES/ ACCESSORIES ACCORDING TO EU MDR 2017/745 Document Number: TF001
CONFIDENTIAL CE TECHNICAL FILE Title All correspondence concerning this technical file should be directed to:
Company Details here
The contents of this file are highly confidential and should not be disclosed to any third party without the prior approval of the manufacturer. PREPARED BY: PRINT NAME Adnan Ashfaq
POSITION
SIGNATURE
DATE
QA/RA Consultant (Pharmi-Med Ltd)
REVIEWED BY: PRINT NAME
POSITION
SIGNATURE
DATE
APPROVED BY: PRINT NAME
POSITION
SIGNATURE
DATE
TECHNICAL FILE FOR CE MARKING MEDICAL DEVICES/ ACCESSORIES ACCORDING TO EU MDR 2017/745
TF001
Revision #
DOCUMENT REVISION HISTORY Author Description of Change
Version: 001
Date
2 of 66
Contents 1.
ADMINISTRATIVE INFORMATION ........................................... Error! Bookmark not defined. 1.1
Part I. List of Terms and Acronyms .......................................... Error! Bookmark not defined.
1.2
Part II. Identification of the Manufacturer & contact person .. Error! Bookmark not defined.
1.3 Part III. European Economic Area Authorized Representative & ImporterError! Bookmark not defined. 1.4
Part IV. Product Identification & Classification ........................ Error! Bookmark not defined.
1.5
Part V. Conformity Assessment Route ..................................... Error! Bookmark not defined.
1.6
Part VI Identification of Notified Body ..................................... Error! Bookmark not defined.
1.7
Part VII Declaration of Conformity ........................................... Error! Bookmark not defined.
1.8
Part VIII Use of Harmonised Standards .................................... Error! Bookmark not defined.
2. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES ..................................................................................... Error! Bookmark not defined. 2.1
Device description and specification ....................................... Error! Bookmark not defined.
Product Code ....................................................................................... Error! Bookmark not defined. Description............................................................................................ Error! Bookmark not defined. Product Code ....................................................................................... Error! Bookmark not defined. Description............................................................................................ Error! Bookmark not defined. 2.2
Device Specification ................................................................. Error! Bookmark not defined.
2.3
Reference to previous and similar generations of the device . Error! Bookmark not defined.
3.
INFORMATION TO BE SUPPLIED BY THE MANUFACTURERError! Bookmark not defined.
4.
DESIGN AND MANUFACTURING INFORMATION ................ Error! Bookmark not defined.
5.
GENERAL SAFETY AND PERFORMANCE REQUIREMENTSError! Bookmark not defined.
6.
BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT ........ Error! Bookmark not defined.
7.
PRODUCT VERIFICATION AND VALIDATION....................... Error! Bookmark not defined. 7.1
Stability:.................................................................................... Error! Bookmark not defined.
7.2
Journey Hazard Testing ............................................................ Error! Bookmark not defined.
7.3
Pre-clinical and clinical data ..................................................... Error! Bookmark not defined.
7.4 Production Verification and Validation; Software Verification and ValidationError! Bookmark not defined. 7.5
Shelf Life ................................................................................... Error! Bookmark not defined.
7.6
Production Verification and Validation; Biological Safety ....... Error! Bookmark not defined.
7.7
Production Verification and Validation; Animal Studies .......... Error! Bookmark not defined.
3 of 66
7.8
Production Verification and validation; Sterilisation ............... Error! Bookmark not defined.
8. TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCEError! Bookmark not defined. 8.1 The post-market surveillance plan drawn up in accordance with Article 84.Error! Bookmark not defined. 9.
Checklist GSPRs ........................................................................... Error! Bookmark not defined. Appendix 1 - Declarations of Conformity ............................................. Error! Bookmark not defined. 10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.Error! Bookmark not defined. Appendix 2 – General Safety and Performance Requirements ChecklistError! Bookmark not defined. Appendix 3 - Risk Analysis documents ................................................. Error! Bookmark not defined. Appendix 4 – Sterilisation Validation -Reports .................................... Error! Bookmark not defined. Appendix 5 - Clinical Evaluation Report ............................................... Error! Bookmark not defined.
4 of 66