Class I Medical Devices (Conformity Assessment Procedure) – 验证评估程序——I 级
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In the case of medical devices with a low risk (class I), like crutches, the manufacturer or his European Representative under his own responsibility may guarantee and declare that the devices meet the requirements of the directive. The manufactuerer makes the technical file available and marks the products.
This is called conformity assessment procedure according to Annex VII of the Medical Devices Directive.