In theory, drugs and medical devices can be very accurately differentiated in terms of their modes of action and thus their intended medical purposes : while drugs develop their effects in a pharmacological, immunological or metabolic manner, medical devices achieve their effect primarily in a mechanical, physical, chemical, physicochemical or similar way. In practice, however, it has been shown that the definition of the product category is not always trivial . The routes to market approval of drugs and medical devices are basically comparable, not least to ensure a comparable level of effectiveness and safety, but they differ considerably in their details.
The evidence to be provided for the safety and effectiveness of the products differs and this has a significant impact on the time frame and the budget to be brought in until the products enter the market. With the new Medical Devices Ordinance, which will come into force in May, the delimitation, especially for material medical devices, will become more blurred and the effort for the manufacturer will once again increase significantly. This presents major challenges for companies in the medical device sector in particular.
In this webinar we would like to shed light on the clinical development according to AMG and MPG (MDD) / MDR and place a special focus on those products for which a clear assignment in one of the two regulatory dimensions is often difficult.
We would like to inform you which products this affects and how an incorrect classification can be avoided. We will provide relevant examples from practice and address the questions of the audience at the end of the webinar.
Our experts in this webinar are:
Bernd Brormann , Senior Director Clinical Research & CRO Services
Ralf G. Sibbing , Managing Partner TentaConsult Pharma & Med GmbH
Price:
Participation in the webinar is free.
Duration:
60 minutes
You can get the invitation via the website of the organizer, the proDERM Institute for Applied Dermatological Research GmbH:
https://www.proderm.de/news/webinare/arzneimittel-oder-medizinprodukt/
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