CE Marking

Medical Device Directive

MEDICAL DEVICE DIRECTIVE ( 93/42/EEC )

 

To view certification processes, please check the Documents given below 

 

Application Forms:

Conformity Assesment Application Form and Agreement (must be filled 2 copies)

-Medical Device Directive Information Form (given below in Documents section)

- Technical File Amendment Form  

- A copy of Trade Registry Gazette which indicates the title, legal tender and the managers having representative and binding authority of the Applicant Firm. For foreign applicants: an equivalent legal document is required (original or notarized document)

- Authorized Signatory List of the authorized persons of the Applicant

- Copy of the Tax Board

Prepayment Receipt 

- Copy of the registration document of the Chamber of Commerce

- List of the Legal Employers

- In case the Applicant and Manufacturing Place are different; confirmed document presenting the agreement between them

- Document manifesting the application advance payment

- TECHNICAL FILE (Hard Copy)

- DESIGN FILE (If necessary) (Hard Copy)

 

To view detailed information about certification processes, please check the Documents given below

 

In order to get TS EN ISO 13485 Quality Management System Certificate together with CE Marking Conformity Assessment Certification, Quality Management System Application Forms are required to be filled as well. These forms can be obtained from www.tse.org.tr

 

Please communicate with us for your questions and our fees.

 

Tel:  90 - 312 416 64 61     

Fax: 90 - 312 416 6282

mdd@tse.org.tr

 


Documents (3)

Return to Old Site