Throughout this guide, guidance is given on the qualification of medical devices and the application of classification rules. There is a detailed explanation of the classification process and how to seek clarification on a medical device's classification.
In-vitro diagnostic medical devices are not covered by this guide.
The guide details, among other things, the reasons for classification and the methods of correctly defining or classifying a product under the Medical Device Regulation.
As defined by the Regulation, a medical device is an item used to treat symptoms in a patient and is classified according to a set of rules. It is the responsibility of the manufacturer to correctly qualify and classify their products before placing them on the EU market.
In order to ensure that a device complies with the Regulation, it needs to be classified and this classification should be agreed with the notified body chosen by the manufacturer to conduct the conformity assessment.
For more detailed information on the Classification of a Medical Device, click this LINK
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