CE marking is a cornerstone to the functioning of the European single market, which allows free movement of goods among not only the member states of the European Union (EU), but also the countries of the European Economic Area (EEA).
For medical devices and in vitro diagnostics (IVDs), CE marking is mandatory for marketing, and the process for achieving a CE mark has become more stringent with the implementation of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulations (IVDR).
In this guide, we explore the regulatory landscape for medical devices and IVDs in the EU, providing insights on every step of the CE marking approval process.