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Technical Documentation
The Technical Documentation must prove that the product fulfils the requirements laid down in the Medical Devices Directive 93/42/EEC. The Technical Documentation for medical devices should take account of the following aspects:
- Table of Contents with revision status and proof of completeness of the file
- Name and address of the manufacturer and/or if necessary: name of the European representative also and all places of manufacturing, excerpt from the commercial register or a registration of a business
- Description of product family including all variations planned and the Intended Use
- Declaration of Conformity
- Proof of fulfillment of the Essential Requirements according to Annex I
- Product classification
- Risk analysis in accordance with EN ISO 14971:2007
- List of the applied standards
- Information for use (e.g. Instructions for Use, Technical description)
- Product identification (e.g. labels, warnings, used symbols)
- Description of Packaging and Labeling
- If applicable, design and production drawings as well as plans of mechanical components and devices ect. (mechanical drawings) and Electrical Circuits (Block Diagram)
- If applicable, results of design calculations and performed testing
- If applicable, used method and validation report of sterilization Biocompatibility
- If applicable, test reports of electromagnetic compatibility (EN 60601-1-2:2007)
- Clinical evaluation according to Annex X, MDD
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