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EU, EU MDR, EU IVDR, Classification EU, EU MDR, EU IVDR, Classification

Classification — Classification of devices

The rules that assign a device to a risk class, which then determines the conformity assessment route and the level of notified body involvement. Under the MDR devices fall into classes I, IIa, IIb and III according to the rules in Annex VIII. Under the IVDR devices fall into classes A, B, C and D under a different Annex VIII rule set.

Reference: MDR Article 51 and Annex VIII; IVDR Article 47 and Annex VIII

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EU, EU MDR, Classification EU, EU MDR, Classification

Up-classification

A device moving to a higher risk class under the regulation than it held under the directives, usually because of a changed or newly added classification rule. The consequence is a different conformity assessment route and, often, notified body involvement where there was none before.

Reference: MDR Annex VIII

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