What kind of device is my medical device?
Manufacturers have to deal with this and many other regulatory questions when working on the intended use, approvals, registrations and target markets of their projects.
Another example: Drugs and medical devices are liable to different legal frameworks in Europe. Your challenge as a manufacturer is the regulatory classification of your product. This requires a precise differentiation in an early stage of development. Therefor it results, that investigations to confirm the marketability of your project are completely different for these product classes. Even for combination products, which consist of a drug- and medical device component, it is necessary to clarify under which directive the product is regulated.
Take advantage of our experience in the creation of an expert opinion regarding differentiation or classification for submission purpose to authorities or notified bodies, or as a basis for discussions and decisions in differentiation- and classification questions for your product.
We gladly provide you with expert opinions or statements. For this purpose, our team and our network consist of experts and specialists. We function as independent partner supporting you with science-based facts in your regulatory environment. With these activities, we want to contribute to the success of your projects and optimize the dialog between you and the authorities.