Drug-Device Combination (DDC) products generated over $120 billion (USD) in global sales in 2019, with this market expected to exceed $200 billion (USD) by 2030. European markets represent almost 30% of these sales, a market share that is likewise expected to grow over the same decade. These figures reinforce the importance of DDC products to pharmaceutical and device manufacturers that sell into the European Union (EU).

DDC products have been around for a while, but there is still confusion on how to approach regulatory issues such as labeling. Are these products treated like a drug, or are they treated like a device? The answer? It depends.

At the same time, EU rules for market approval and oversight of medical device products have become more detailed and more demanding with the advent of the Medical Device Regulation (MDR). Many new requirements have come into effect that affect areas of device design, manufacturing, clinical evaluation, and post-market surveillance. These new requirements also include changes for regulatory labeling.

This paper presents an overview of how DDC products are regulated in the EU and discusses the challenges of complying with new labeling requirements mandated by the MDR.

MDR Impacts on EU Regulatory Labeling of Drug-Device Combination Products

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