Diapharm supports clients in developing medical devices and in vitro diagnostics (IVDs) – from identifying new ideas to product development in compliance with standards and guidelines.
We provide our expertise as needed on a case-by-case basis or as part of larger-scale projects. In everything we do, we always remain focused on the requirements set forth in Section 7.3 of ISO 13485 (“Design & Development”).
The European marketability of medical devices depends on the manufacturer’s declaration of conformity. The necessary conformity assessment procedures, commonly known as “medical device approval”, are defined in Directives 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostics.
A manufacturer’s declaration of conformity may refer to variants of the medical device in question, which may be marketed with different product names through different sales channels and in different markets.
Unlike with marketing authorisations of medicinal products, manufacturers cannot sell the European marketability of their medical devices. However, they may license (co-)marketing rights to interested parties. We support clients in identifying suitable suppliers and marketing partners, and we can help manage the negotiation of licensing agreements on request.
Did you know? Diapharm offers marketing licences for purchase for a wide range of IVDs and medical device “approvals”!