Class 1 Medical Devices

Class I medical devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Most Class I medical devices are exempt from the good manufacturing practices and/or the FDA notification regulations or the Indian FDA (CDSCO) regulations.

Class 1 device CE marking, Notified Body involvement is not mandatory. Class 1 products manufactures ISO 13485 implementation and certification is not required. Minimum level of GMP compliance is recommended. In short, some controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device is required.

Class 1 devices are again divided into two:

All class 1 devices can affix CE Mark by self declaration. The manufacturer is responsible for ensuring that his product complies with all the relevant Essential Requirements of the Directive and must complete the Essential requirement Check list.

More details about process of certification click here .

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