Technical file

For all Classes of medical devices (I, IIa, IIb, III) the manufacturer must have and keep up-to-date a technical documentation, also called a technical file or a device master file. This documentation demonstrates compliance with essential requirements (Annex I of the 93/42/EEC).

Minimum content of technical file should include:

  1. Table of contents
  2. General information concerning the structure and use
  3. EC declaration of conformity and classification to 93/42/EEC annex IX
  4. Name and address of the manufacturer / European Representative and any manufacturing plants
  5. Product description
    • Product description including any variants
    • Photographs of the product
    • Photographs of product usage
    • Brochures, advertising, catalogues (if available)
  6. Product specifications
    • List of applicable standards
    • Parts list, list of components
    • Assembly and/or manufacturing drawings
    • Sub-assembly drawings, drawings of components (circuitry)
    • Specifications of materials used inc. data sheets
    • In case of a drug-device combination: statement about the substance(s) used (if applicable results of the consultation- procedure)
    • Manufacturing specification
    • Sterilization specification
    • Packaging specification
    • QA specification (e.g. QC specs, in-process and end-controls, end-release etc.)
    • Labelling, accompanying documents, package insert (e.g. EN 980, ISO 15223)
    • Description about the creation of a Lot or Charge No.
    • Instructions for use (e.g. EN 1041)
      • Intended / clinical use
      • Indications, contra-indications
      • Operating instructions, instructions for use
      • Warnings / precautions
    • Service Manual
    • OEM contracts or supplier certificates
  7. Product verification
    • Testing data and reports, functionality studies, wet lab or bench top testing
    • Materials certificates/reports on stability, biological tests, cleanroom-surveillance
    • EMC testing and certificates
    • Compatibility studies (connection to other devices)
    • Risk management- documentation (EN ISO 14971)
    • Clinical data (e.g. Article 15 / annex 10, MEDDEV 2.7.1, EN 14155-1/-2)
  8. Product validation
    • Validation of the packaging/ageing studies
    • Process validation (e.g. sterilization, manufacturing, production)
    • Software validation

The working group of Notified Bodies has issued recommendations for the structure of the technical file in the guidance NB-MED/2.5.1/Rec.5 rev.4 “Technical Documentation”.

The technical file should in any case be available in an official language of an EU member state and available on request for the whole product life cycle, but at least for a period of 5 years from the production of the last product, with the authorised representative in the EU.