Essentials of European Medical Device Regulatory Affairs

Classification of medical devices How to classify?

Key points • Intended purpose • Confirm it is a medical device • Consider the definitions • Consider the implementing rules • Determine the applicable rule • Classify

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How to Apply the Rules

• Manufacturer decides on the basis of the decision rules in the Directive (Annex IX) and the intended purpose of the device

• Decision criteria: time, invasiveness, powered or not (active/non-active), presence of drugs

• All rules must be considered

• For multipurpose devices the highest class applies

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