When Devices Meet Medicines: Chemistry, Biology, and Regulatory Synergy

Combination Products (CP) include a combination of a medical device, a drug, and a biological product. Their complexity arises from the interaction between components, where the drug may alter the device's safety profile, and the device can impact the drug's function, potentially leading to unforeseen safety or performance issues. Regulatory frameworks vary:

For example, for U.S. FDA CPs are categorised based on their Primary Mode of Action (PMOA) into Single-entity, Co-packaged and Cross-labeled. Under EU Regulations no dedicated CP regulation exists. The applicable framework depends on the PMOA, leading to compliance with either Directive 2001/83/EC (MPD) or Regulation 2017/745 (MDR), with some MDR requirements still applying under MPD governance.

Ensuring CP safety, including biocompatibility, is essential. Various guidelines apply to CP components, but ISO 10993 is the key standard for biological risk assessment. Chemical Characterisation should be prioritised, and biological tests should be conducted on the final medical device or representative samples, including sterilisation if necessary.