EMA Guidance: Quality Documentation for Drug-Device Combination Products

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EMA Guidance: Quality Documentation for Drug-Device Combination Products

As we all know, there are continuous updates to the existing technologies alongside the advent of new ones. Incorporating these technologies into the drug-device combination products for tracking and monitoring purposes is increasing day by day. Given the continuous technological developments and wide range of medical devices or device parts that may be used with a medicinal product, it is essential to have appropriate guidelines on what type of information should be provided in a combination product’s Regulatory submission.