EMA Guideline on the quality requirements for drug-device combinations

Documentation expected for Drug-Device Combinations (DDCs)

In recent years there has been an increase in the number of scientific advice requests and marketing authorization applications (MAAs) where a medicinal product incorporates, either in an integral or non-integral manner, a medical device/medical device component (hereafter, both terms are called “device(s)”, for the use of the medicine. The availability of commercialized devices with automated functions is increasing and this may benefit patients with regular and long-term dosing requirements in an outpatient setting, either by self-administration or with the support of a professional or lay caregiver. This reduces the burden on patients and on health care systems.

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