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Medical devices

Directive EEC 93/42

IMQ is a Notified Body for all procedures required by the Directive.

The directive establishes 4 classes of devices based on their hazardous nature.

The manufacturer is required to identify the class of their product, based on the classification regulations set out in the directive.

The assistance of a notified body is not required for class 1 devices.

Manufacturers of devices classed as 2 and above must follow a certification procedure by a Notified Body such as IMQ.

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