Form-No.

: 01 03 00 19e Proposal for a General Product Documentation

0.1 Cover page (company, title, No., release, signature etc.)

0.2 Content (e. g. as document master file)
0.3 General information about structure and usage

PART 1 DEVICE MASTER FILE

1. EC declaration of conformity and classification according to 93/42/EEC Annex IX
2. Name and address of the manufacturer/representative and manufacturing plants
3. Product description
 Product description including planned variants
 Photographs spotlighting the product
 Photographs spotlighting the usage
 Brochures, advertising material (if available)
4. Product specification
 Descriptions and Remarks required for the understanding of the documents
 List of applicable standards
 Part lists
 Assembly and/or manufacturing drawings etc.
 Subassembly drawings, drawings of components (circuitry)
 Specifications of materials used incl. data sheets
 Statement about the pharmacological effect (if necessary result of the consultation procedure)
 Manufacturing specification
 Sterilization specification
 Packaging specification
 QA specification (e. g. QC specs, in-process- and end- controls)
 Labeling, accompanying documents, package insert (e. g. EN 980, ISO 15223)
 Description of the creation of Lot No. or Charge No.
 Instruction for use (e. g. EN 1041)
 Field of use and application
 Indications/contraindications
 Operating and use instructions
 Warnings/precautions
 Service Manual
 OEM- contracts and/or supplier certificates
5. Product verification
 Result of manufacturing drawings
 Result of testings (e. g. material testings, pharmacological-toxicological examinations, data of
biocompatibility, examinations of stability, cleanroom surveillance)
 Results of technical testings (e. g. EMC, electrical safety) and certficates if applicable
 Compatibility studies (connection to other medical devices)
 Risk management documentation (EN ISO 14971)
 Clinical data (especially for products of class IIb and III as well as implantable products)
(e. g. Article 15/Annex 10, MEDDEV 2.7.1, EN 14155-1/-2)
6. Product validation
 Validation of the packaging/ageing studies (usability duration)
 Process validation (e.g. sterilization, manufacturing, production)
 Software validation

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Form No. 01 03 00 19e

PART 2 ESSENTIAL REQUIREMENTS ACCORDING TO ANNEX 1 EC DIRECTIVE 93/42/EEC

Please indicate how the Essential Requirements are fulfilled. This can be done either by using the relevant standards and/or in any other cases by a describing the
solutions implemented by you.
NA A Applied Test(s) done Remarks  Notes
Standard(s) (e. g. specified text position in the product documentation)
I. GENERAL REQUIREMENTS
1.

2.

3.

4.

5.

6.

6.a

NA A Applied Test(s) done Remarks  Notes

Standard(s) (e. g. specified text position in the product documentation)
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
7. CHEMICAL, PHYSICAL AND BIOLOGICAL PROPERTIES (IF NOT APPLICABLE, FURTHER ON WITH NO. 8.)
7.1

7.2

7.3

7.4

7.5

7.6

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Form No. 01 03 00 19e

NA A Applied Test(s) done Remarks  Notes

Standard(s) (e. g. specified text position in the product documentation)
8. INFECTION AND MICROBIAL CONTAMINATION (IF NOT APPLICABLE, FURTHER ON WITH NO. 9)
8.1

8.2

8.3

8.4

8.5

8.6

8.7

9. CONSTRUCTION AND ENVIRONMENTAL PROPERTIES (IF NOT APPLICABLE, FURTHER ON WITH NO. 10)
9.1

9.2

9.3

10. DEVICES WITH MEASURING FUNCTION (IF NOT APPLICABLE, FURTHER ON WITH NO. 11)
10.1

10.2

10.3

11. PROTECTION AGAINST RADIATION (IF NOT APPLICABLE, FURTHER ON WITH NO. 12)
11.1 General
11.1.1

11.2 Intended radiation

11.2.1

11.2.2

11.3 Unintended radiation

11.3.1

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Form No. 01 03 00 19e

NA A Applied Test(s) done Remarks  Notes

Standard(s) (e. g. specified text position in the product documentation)
11.4 Instructions
11.4.1

11.5 Ionizing radiation

11.5.1

11.5.2

11.5.3

12. REQUIREMENTS FOR MEDICAL DEVICES CONNECTED TO OR EQUIPPED WITH AN ENERGY SOURCE (IF NOT APPLICABLE , FURTHER ON WITH NO. 13)
12.1

12.2

12.3

12.4

12.5

12.6 Protection against electrical risks

12.7 Protection against mechanical and thermical risks

12.7.1

12.7.2

12.7.3

12.7.4

12.7.5

12.8 Protection against the risk posed to the patient by energy supplies or substances
12.8.1

12.8.2

12.9

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Form No. 01 03 00 19e

NA A Applied Test(s) done Remarks  Notes

Standard(s) (e. g. specified text position in the product documentation)
13. INFORMATION SUPPLIED BY THE MANUFACTURER
13.1

13.2

13.3, a - n

13.4

13.5

13.6, a - q

Remarks:
 This form is only a proposal for the structure of a product documentation
 This proposal tries to give a guideline for all medical products; i. e. it is necessary to decide for each specific device if the mentioned points are relevant for this
device.
 In part 2 it is necessary to declare as detailed as possible in the table, where the fulfilments of the requirements of Annex I are stated in the product documentation.

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