The Medical Devices Introductory Course 2020

How to apply the Rules

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

Decision criteria: time, invasiveness, powered or not (active/non-active), presence of medicinal product / animal tissue

All applicable rules must be considered and the highest classification applies

For multipurpose devices the highest class applies

The Organisation for Professionals in Regulatory Affairs

How to classify your medical device

1. Manufacturer must determine on the basis of the intended purpose 2. Confirm it is a medical device 3. Consider the definitions 4. Consider the implementing rules 5. Decide on the applicable rule(s) 6. All rules must be considered with highest possible classification applying 7. Classify

The Organisation for Professionals in Regulatory Affairs