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

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

    Preparing your Medical Device Combination Products for EU Launch? Learn more on how to apply MDR Article 117 and the EMA Directive.

    September 30, 20211 min read
    • 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)

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