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The Medical Device Developer's Guide to IEC 60601-1

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Example Contents of a Technical File for the Medical Devices Directive

 

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

FDA

Medical Devices Directive

Technical File

Other Countries

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The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from www.iec.ch. IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication.  The material is reproduced or rewritten with their permission.