PART 1 DEVICE MASTER FILE
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1 Form-No.: e 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 /-2) 6. Product validation Validation of the packaging/ageing studies (usability duration) Process validation (e.g. sterilization, manufacturing, production) Software validation MEDCERT Form Nr. F e / Rev. 2 / / F e.doc Page 1 of 5
2 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. I. GENERAL REQUIREMENTS a II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 7. CHEMICAL, PHYSICAL AND BIOLOGICAL PROPERTIES (IF NOT APPLICABLE, FURTHER ON WITH NO. 8.) MEDCERT Form No. F e / Rev. 2 / / F e.doc Page 2 of 5
3 8. INFECTION AND MICROBIAL CONTAMINATION (IF NOT APPLICABLE, FURTHER ON WITH NO. 9) CONSTRUCTION AND ENVIRONMENTAL PROPERTIES (IF NOT APPLICABLE, FURTHER ON WITH NO. 10) DEVICES WITH MEASURING FUNCTION (IF NOT APPLICABLE, FURTHER ON WITH NO. 11) PROTECTION AGAINST RADIATION (IF NOT APPLICABLE, FURTHER ON WITH NO. 12) 11.1 General Intended radiation Unintended radiation MEDCERT Form No. F e / Rev. 2 / / F e.doc Page 3 of 5
4 11.4 Instructions Ionizing radiation REQUIREMENTS FOR MEDICAL DEVICES CONNECTED TO OR EQUIPPED WITH AN ENERGY SOURCE (IF NOT APPLICABLE, FURTHER ON WITH NO. 13) Protection against electrical risks 12.7 Protection against mechanical and thermical risks Protection against the risk posed to the patient by energy supplies or substances MEDCERT Form No. F e / Rev. 2 / / F e.doc Page 4 of 5
5 13. INFORMATION SUPPLIED BY THE MANUFACTURER , a - n , 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. MEDCERT Form No. F e / Rev. 2 / / F e.doc Page 5 of 5
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