CE Marking

In Vitro Diagnostic Medical Devices Directive

IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVE ( 98/79/EC )

 Our Scope

Product Group

Module

IVD 0300 List B

Reagents, reagent products and devices for self- diagnosis, including related calibrators and control materials, for determining, detection, quantification,diagnosing, evaluating

IVD 0301 Anti-Duffy and anti-Kidd

IVD 0302 Irregular anti-erythrocytic antibodies

IVD 0303 Congenital infections: rubella, toxoplasmosis

IVD 0304 Hereditary disease: phenlyketonuria

IVD 0305 Human infections: cytomegalovirus, chlamydia

IVD 0306 HLA tissue groups: DR, A, B

IVD 0307 Tumoral marker: PSA

IVD 0308 Risk of trisomy 21 (incl.software)

IVD 0309 Device for self-diagnosis: device for the measurement of blood sugar

IVD 0400 Devices for self-testing

IVD 0401 Clinical Chemistry

IVD 0402 Haematology

IVD 0403 Immunology

IVD 0404 Molecular biology

IVD 0405 Pregnancy and ovulation

IVD 0406 Specimen receptacles

MDS 7200 IVD Specifics

 

MDS 7206 IVDs in sterile condition

MDS 7207 IVDs utilising micromechanics

MDS 7208 IVDs utilising nanomaterials

MDS 7209 IVDs utilising biological active coating and/or material

MDS 7210 IVDs utilising material of human origin

Module A+: EC Declaration of Conformity and Design Examination

Module D: Production Quality Assurance

Module H: Full Quality Assurance

 

Application Forms:

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

Information Form

- Technical File Amendment Form  

- Prepayment Receipt 

- 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

- 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)

 

Please communicate with us for your questions and our fees. 

 

 

Responsible for In Vitro Diagnostic Medical Devices Directive

BERNA KANKILIÇ

Tel: 90 - 312 416 64 61
Fax: 90 - 312 416 62 82 

 

ivd@tse.org.tr

dkankilic@tse.org.tr

 

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