Medical device combination products: what regulations should you apply before marketing them in the EU?

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    References

    • QWP-BWP Guideline on medicinal products used with a medical device (europa.eu)
    • Medical devices | European Medicines Agency (europa.eu)
    • Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (europa.eu)
    • MDR Article 117: A New Implication for Drug-device Combination Products (celegence.com)