In theory, medicinal products and medical devices can be very appropriately distinguished in terms of their modes of action and thus their medical purposes: while medicinal products exert their effect in a pharmacological, immunological or metabolic manner, medical devices achieve their effect predominantly by mechanical, physical, chemical, physicochemical or similar means. In practice, however, it becomes apparent that the determination of the product category is not always trivial. The routes to market approval for drugs and medical devices are basically comparable, not least to ensure a comparable level of efficacy and safety, but in their details they differ considerably.
The proof of safety and efficacy that has to be provided differs, and this has a significant impact on the time and budget required before the products can be launched on the market. With the new Medical Device Regulation (MDR) 2017/745 (EU), which comes into force in May, the demarcation becomes more blurred, especially for material medical devices, and the effort for the manufacturer increases significantly once again. This poses major challenges for medical device companies in particular.
In this webinar, we would like to shed light on clinical development according to AMG and MPG (MDD) / MDR, with a special focus on products for which it is often difficult to clearly assign them to one of the two regulatory dimensions.
We would like to inform about which products this concerns and how an incorrect classification can be avoided. To this end, we will provide relevant examples from practice and address questions from the audience at the end of the webinar.
Our experts in this webinar are:
Bernd Brormann, Senior Director Clinical Research & CRO Services.
Ralf Sibbing, Managing Partner TentaConsult Pharma & Med GmbH
Participation in the webinar is free of charge.