Drug device combination products are therapeutics or diagnostics that are a combination of medical devices, drugs and/or biologics. For example, a transdermal patch (medical device) that delivers a specific dose of pain-reducing medication. Because these medical device products also contain a pharmaceutical or biological component, combination products mean having to navigate unique challenges within the vast regulatory landscape of both Pharma and MedTech.
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In a 1-day training targeting Pharma professionals, Läkemedelsakademin offers an introduction to EU regulation for combination products (Introduktion till EUs regelverk för kombinationsprodukter – för dig inom Pharma). This course covers the Medical Device Regulation (MDR) and can also be taken by MedTech professionals as a refresher to learn more about the new EU regulation for medical devices.