A medicinal product with a medical device component is termed a “combination product”. One classic example is a prefilled syringe. Sebastian Fuchs (Medical Devices Surveillance Inspector in the Market Surveillance division) explains what the combination involves: "While the syringe, the "application container", is a medical device, the contents of the syringe are, for example, a vaccine or medicine."
Difference between integral and non-integral
Basically, there are two types of combination products. In a non-integral combination product, the medical device component is included in the packaging or provided separately – a cough syrup is a good example: "The bottle with the cough syrup (medicinal product) and the measuring cup for the correct dosage (medical device) are provided together as a unit in the same packaging", says Bernhard Spörri (Head of the Quality Assessment unit in the Authorisation division). He continues: "In an integral combination product, the medicinal product component is manufactured together with the medical device component as a combined unit that is intended exclusively for use in this specific combination." Examples include the above-mentioned prefilled syringes and prefilled infusion pumps or a prefilled asthma inhaler. Medical devices containing a medicinal product also exist, for example a drug-coated stent.
"Sitting around the same table, we can combine our expertise in medicinal product authorisation and medical device investigation in a targeted manner."Bernhard Spörri
The task of Swissmedic
Swissmedic has appointed an expert team to define the internal processes for assessing combination products and the associated harmonisation with the stricter regulatory requirements. "Differing legal rulings exist in some cases for medicinal products and medical devices. This is one of the reasons why the Management Board of Swissmedic has set up an interdepartmental specialist group to evaluate how these rules apply to combination products," explains Bernhard Spörri. That's why medicinal product and medical device experts sit around the same table in this specialist group. "This allows us to assess and evaluate the two aspects together. The first task of the specialist group is to prepare a strategic policy decision for the attention of the Management Board. For example, they might discuss whether Swissmedic should produce expert reports for the medicinal product part of an integral medical device (e.g. antibiotic-coated hip implants). Because highly innovative combination products may be involved, the specialist group must assess the question as to whether Swissmedic possesses sufficient specific expertise to carry out these tasks", says Bernhard Spörri. "But the overriding specialist group is also meant to act as a centre of expertise for questions on combination products", says Sebastian Fuchs. Conclusion: the specialist group is designed to serve as an interdisciplinary body for addressing questions from both sides, without becoming involved in the operational processes of authorisation and market surveillance.