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Articles tagged with: Classification

Reusable Surgical Instruments: Notified Body

Even Class I reusable surgical instruments must be evaluated by the notified body, according to MDR.

Davide Valtorta

Classification Conformity assessment Surgical instruments

Medical Device Software in the MDR

A classification rule applicable to all medical device software stipulates that these fall at least into class IIa.

Davide Valtorta

Classification Software