Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto. Table of Contents Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare...
The second blog in our series covering Czech advertising rules for medical devices, this article describes specific rules to be followed in the case of advertising medical devices to healthcare professionals and laypersons in terms of the scope of information and the...
The article describes a new instruction dedicated to general advertising rules and the way they should be applied concerning medical devices. The document indicates permitted and prohibited advertising activities and highlights the most important aspects to be...
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to the applicable classification rules. The document is intended to provide medical device...