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Quick due diligence checklist non-integral DDC

Pharmaceutical companies that want to place a non-integral drug-device combination on the EU market need to work together with a medical device manufacturer. The device must be CE-certified for the right intended purpose before the market authorization application can be filed. Therefore, it is important for the drug company to keep sufficient control over the … Read more

Quick due diligence checklist integral DDC

Pharmaceutical companies that work together with a medical device supplier for their integral drug-device combination need to have sufficient control over the readiness of the required documentation. Especially in the early stages of a project, these matters can be challenging. The checklist can provide an indication of the readiness of the documentation for the device … Read more

Drug-device combinations need a specific MD department within a pharma company

DDC There is a growing trend in the pharmaceutical field where we see companies not only develop their drug but also develop the device necessary to deliver the drug as intended. These drug-device combinations (DDC) come in various types and shapes: In some of these combinations, the device is considered to be a medical device … Read more

Devices that are used together, components, accessories, systems, procedure packs, and the rest…

Do standalone devices exist? Medical devices are typically used in a wider therapeutic or diagnostic context. They are often used together or sequentially with other products, often medical devices or medicinal products, and sometimes also other types of products. They may be connected or compatible, they may interface or be used simultaneously. They may use … Read more