Why Regulatory Classification is Crucial
The regulatory differentiation between pharmaceuticals and medical devices is one of the central issues in the healthcare market. The correct classification has a significant impact on the approval process, clinical requirements, regulatory costs, and the overall market entry strategy of a product.
Especially for innovative or material products, classification often proves to be complex, which is why a thorough regulatory assessment is necessary.
The difference between pharmaceutical and medical device
The fundamental difference lies in the primary effect of a product for which it is intended.
The primary effect of medical devices in or on the human body is predominantly achieved thru physical or mechanical influences.
Pharmaceuticals however, exert their effect thru a pharmacological, immunological, or metabolic approach and thus actively intervene in physiological processes.
Their classification depends not only the active ingredient but also the combination of mechanism of action, intended purpose, and product properties.
Why does the intended purpose matter that much?
In regulatory practice, the advertised intended purpose often determines how a product is classified.
Even minor deviations in the description can result in a different regulatory assessment. A product for stool regulation can be classified as a medical device if its effect is primarily based on physical processes of water binding. If, on the other hand, the stabilization of the electrolyte balance is emphasized, a metabolic effect can be assumed, and the product is considered a medicine.
Our service with Regulatory Classification
A misclassification can have extensive repercussions, including additional clinical requirements, extended development times, or increased regulatory costs.
Manufacturers can reduce regulatory risks and make their development processes more efficient if they analyze the mechanism of action and intended purpose early on.
WQS supports companies in the regulatory evaluation of products, classification according to MDR, and the development of a legally secure market entry strategy.
Visit our website for that: https://us.wqs.de/pharmaceutical-and-medical-device-classification/
or contact us directly: https://us.wqs.de/contact/
