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[CE/MDD] Technical Construction File
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- 2017-01-05 19:21:00
CE/MDD 의 TCF 구성에 대해 안내드립니다.
TCF는 Technical Construction File의 약자로, CE marking을 하고자 하는 제품의 기술적인 내용을 작성한 문서이며 일반적으로 다음과 같은 목차를 따르고 있습니다.
* Content of Technical Files for Medical Devices
1. IDENTIFICATION DATA
- Manufacturer
- Notify Body
- Device Classification
- ETC.
2. GENERAL DESCRIPT-xION OF THE PRODUCT
- Introduction
- Intended use
- Principle
- Content of products(devices, kits)
- Shelf-life
- Storage and stability
- Assay, Testing
- ETC.
3. REGULATORY STANDARD APPLIED
- List if the applied norms, standards
- Essential requirements
- ETC.
4. RISK ANALYSIS
- According to EN ISO 14971:2012
5. CLINICAL EVALUATION
- A clinical evaluatioin of the results of clinical data and clinical investigations generated from use ot he device itself
- CER (Clinical Evaluation Report)
- MEDDEV 2.7/1 Clinical Evaluation, 2.7/3 Clinical investigation
6. Label and package
- Labelling
- Packaging
- ETC.
7. Raw Materials
- Strategic raw material
- Information on substances and dangerous materials
- ETC.
8. SPECIFICATION OF THE PRODUCT
9. EVALUATION RESULTS
- Depend on device:
.Electric safety
.EMC
.Biochemical performances.
.Toxicity studies
.Bio-compabiltiy
.etc
10. STABILITY DATA
11. PRODUCTION DOCUMENTS
- Method of manufacture and procedures standards
- Validation
- Equipments
- Maintenance and controls
12. DECLARATION OF CONFORMITY
의료기기의 CE marking 획득은 등급에 관계없이(Class I ~ Class III)
당사의 기술지원 컨설팅이 가능하오니 많은 문의주시기 바랍니다.
TCF는 Technical Construction File의 약자로, CE marking을 하고자 하는 제품의 기술적인 내용을 작성한 문서이며 일반적으로 다음과 같은 목차를 따르고 있습니다.
* Content of Technical Files for Medical Devices
1. IDENTIFICATION DATA
- Manufacturer
- Notify Body
- Device Classification
- ETC.
2. GENERAL DESCRIPT-xION OF THE PRODUCT
- Introduction
- Intended use
- Principle
- Content of products(devices, kits)
- Shelf-life
- Storage and stability
- Assay, Testing
- ETC.
3. REGULATORY STANDARD APPLIED
- List if the applied norms, standards
- Essential requirements
- ETC.
4. RISK ANALYSIS
- According to EN ISO 14971:2012
5. CLINICAL EVALUATION
- A clinical evaluatioin of the results of clinical data and clinical investigations generated from use ot he device itself
- CER (Clinical Evaluation Report)
- MEDDEV 2.7/1 Clinical Evaluation, 2.7/3 Clinical investigation
6. Label and package
- Labelling
- Packaging
- ETC.
7. Raw Materials
- Strategic raw material
- Information on substances and dangerous materials
- ETC.
8. SPECIFICATION OF THE PRODUCT
9. EVALUATION RESULTS
- Depend on device:
.Electric safety
.EMC
.Biochemical performances.
.Toxicity studies
.Bio-compabiltiy
.etc
10. STABILITY DATA
11. PRODUCTION DOCUMENTS
- Method of manufacture and procedures standards
- Validation
- Equipments
- Maintenance and controls
12. DECLARATION OF CONFORMITY
의료기기의 CE marking 획득은 등급에 관계없이(Class I ~ Class III)
당사의 기술지원 컨설팅이 가능하오니 많은 문의주시기 바랍니다.
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