Module 3 2019

Medicine-Device Borderline and Classification

• Depends on the principal mode of action of the product in the indication

• A product is EITHER a medicinal product OR a medical device

• Europe has two sets of legislation and regulatory systems that operate differently

• Combinations of medicines and devices

(called drug-device combinations or DDC) are common and provided for in legislation but there is no ‘combination product’ classification

• For combination products, the two sets of legislation work together but do not duplicate requirements

The Organisation for Professionals in Regulatory Affairs

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