HM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development


The session opened with an overview of the European regulatory pathways for medicinal products and medical devices (MD)/ in vitro diagnostics (IVDs) by Stiina Aarum. While the EMA reviews the marketing authorisation for a medicinal product, MD/IVD are assessed by a notified body (NB) of choice. For medicines used in combination with a MD, the EMA will assess safety and efficacy of the medicine used in combination with the device as part of the marketing authorisation application (MAA).

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