|
Contents of a Device Master File 1.1 EC declaration of conformity and classification
according to ANNEX IX.
1.2 Name and address of the manufacturer/European
Representative
1.3 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
(if available)
2. Product specification
- Parts list, list of components
- Drawings, assembly drawings
- sub-assembly drawings, drawings of components
- Specifications of materials used incl. data sheets
- List of standards applied
- Details of substance(s) used (in the event of drug + device
combination)
- Manufacturing specifications
- Sterilisation specifications
- Packaging specifications
- QA specifications (QC specs., in-process controls etc.)
- Labelling, accompanying documents, package insert (DIN EN
389, prEN 980)
- Instructions for Use (prEN 1041)
- Service Manual
3. Product verification
- 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 (DIN EN 1441)
- Clinical data (Article 15/ Annex 10, DIN EN 540)
- List of requirements (Annex 1) indicating cross-reference
with documentation
Return To Previous Page
|
