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Qualification and classification of medical devices

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).

Clarity to the classification complexity

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.

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Labquality

How can we help?

Even though some guidance has been provided for interpreting the classification rules, the classification of a device can sometimes be complicated. Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
Meeri Säily

Contact us for more information

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Meeri Säily
Sales Director, Consulting and Crinical Trials
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meeri.saily@labquality.com

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