Essential Requirements
Essential Requirements are the requirements for safety and performance specified in Annex I of the three medical device directives.Essential Requirements are divided into
- Part I (i.e.,– general requirements) and
- Part II (i.e., – requirements for design and construction).
Evidence of conformity must be provided for all general requirements in Part 1 for all devices—regardless of risk classification, design or construction.The Design and construction requirements in Part 2 may be not applicable, depending upon your device.
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ESSENTIAL REQUIREMENTS Part I – General Requirements 1. Risk Reduction & Acceptable Risk/Benefit 2. Safety and Risk Control 3. Intended Performances 4. Lifetime of the Device 5. Transportation & Storage 
6. Side-effects must Constitute Acceptable Risk 6a.Clinical Evaluation
7. Chemical, Physical & Biological Properties 8. Infection & Microbial Contamination 9. Construction & Environmental Properties 10.Device with a Measuring 11.Protection Against RadiationFunction 12.Devices with an Energy Source 13.Information Supplied by the Manufacturer |
