Combination Products

A combination product is a product that incorporates a medical device and/or a drug and/or a biologic — combining any two of these product categories, all three, or sometimes with more than one of the individual elements.

The primary usage of the product will determine whether it will be classified and approved under the medical device legislation or medicinal product legislation. Is it a medicine which is delivered via device or does the product have a mechanical action which incorporates a medicine that is ancillary to the mechanical action? Differences too will exist between the interpretation of the classification in different target countries. What might be a medical device in one country, might be classified as a medicine in another.

Since the Real Regulatory team has expertise in both areas, we have built up substantial experience in the support of combination products of both types. We have experience in some products that are classified differently in Europe, to the classifications in US, Australia and Canada.

The process and data requirements needed for approval of a combination product are similarly determined by whichever legislation applies, therefore please refer to the medicines or medical devices service sections, accordingly.


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