Essentials of European Medical Device Regulatory Affairs

Classification of medical devices Classification criteria Degree of invasiveness (2) MDR Annex VIII • Reusable surgical instrument - an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which are intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out

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Classification of medical devices Classification criteria

Classification rules in the MDR MDR Annex VIII 1 – 4 Non invasive devices

5 – 8 Invasive devices 9 – 13 Active devices 14 – 22 Special rules

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