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

HM5

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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