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The qualification of a device as a medical device or an in vitro medical device is first established in the regulatory plan created for the device. The qualification is justified based on the definition of a medical device as set out in Article 2 of MDR (2017/745) and the definition of an in vitro medical device set out in Article 2 of IVDR (2017/746). It is important to determine a correct risk class for the device as the risk class determines the applicable conformity assessment procedure required for regulatory submission. The classification of the device is based on its intended purpose. Annex VIII of both MDR (2017/745) and IVDR (2017/746) define the rules for device classification. |
Even though some guidance has been provided for interpreting the classification rules, the classification of a device can sometimes be complicated.
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