Drug Device Combination Products - Navigating Regulatory Challenges and Pitfalls in the EU

In Collaboration with EY.

Drug-device combinations (DDCs) are products that include both a medical device and medicinal product constituent part.

There are two main types of combination products:

• Integral: The medical device and medicinal product form one single integrated product.

• Co-packaged: The medical device and medicinal product are separate items packed together in the same secondary packaging.

In the EU, combination products can be regulated under either the Medical Product Directive (Directive 2001/83/EC)1 as a medicinal product or the Medical Device Regulation (2017/745; MDR)2 as a medical device.

For co-packaged combination products, the medical device and the medicinal product are regulated individually under their respective regulations. However, for integral combination products, the regulation that will govern the combination product is determined based on the product’s principal mode of action.

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