The basic requirements and harmonized standards of the EU Medical Device Directive

The basic requirements of medical devices are the core part of the directive. Appendix 1 of the three medical device directives lists the basic requirements for medical devices to which the directive applies. Microfluidic Chip ManufacturerThese basic requirements cover all aspects of the product, including general requirements and special requirements for different types of medical devices.

For example, there are 14 basic requirements in Appendix I of the Medical Device Directive (EC-Directive 93/42/EEC), including six general requirements and eight special requirements. The main research contents of the six general technical requirements are:

1. The device must be safe. The risk-benefit ratio must be within an acceptable range.

2. The safety management factors of the enterprise must be taken into consideration when the device is designed, and the recognized technology should be adopted. In order to eliminate or minimize the risk of the instrument,vital signs monitor if the risk cannot be eliminated, it is necessary to take protective measures and notify the user of the remaining risk after the protective measure fails.

3. The device must meet the performance specified by the manufacturer.

4. We must be able to effectively guarantee the safety and effectiveness of the device during the lifetime of the device’s network.

5. Under reasonable transportation and storage conditions, the safety and effectiveness of the instrument must not be affected.

6. The side effects of using the instrument must be within the acceptable range.related articles:

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EU Medical Device Regulatory Model

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