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Example Contents of a Technical File for the Medical Devices Regulations (2017/745)
1. Cover Page (Company, Product/Product Group, Document ID)
2. Index
3. EC declaration of conformity and classification.
4. Name and address of the Manufacturer/European Representative and Manufacturing Plants
5. Product description including:
- All variants
- Intended clinical use
- Indications / contraindications
- Operating instructions / instructions for use warnings / precautions
- Photographs highlighting the product photographs highlighting the usage
- Brochures, advertising, catalogue sheets, marketing claims
6. Product specification including:
- Parts list
- Drawings, assembly drawings
- Sub-assembly drawings
- Drawings of components
- Specifications of materials used incl. data sheets
- List of standards applied
- Manufacturing specifications
- Sterilisation specifications (if required)
- Packaging specifications
- QA specifications (QC specs., in-process controls etc.)
- Labelling
- Accompanying documents
- Package insert
- Instructions for Use
- Service Manual
7. Product verification including:
- Testing data and reports
- Functionality studies
- Wet lab or bench top testing
- Materials certificates / reports on biological tests
- EMC testing and certificates
- Validation of the packaging / ageing studies
- Compatibility studies (connection to other devices)
- Risk analysis (ISO 14971)
- List of requirements (Annex 1) indicating cross-reference with documentation
- Clinical Data
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