Class IIa medical devices are among the most common products on the European market. This article explains which products fall into this class, which classification rules are relevant, and what regulatory consequences this has.
On December 16, 2025, the European Commission published its proposal for revising the MDR and IVDR , already titled MDR 2.0 and IVDR 2.0 respectively. But will manufacturers really benefit from it? This article provides the answers.
With the UDI system, the EU has introduced an obligation to identify and register medical devices that goes far beyond what is still required under the MDD. The Medical Device Regulation (MDR) even requires a UDI for standalone software. Read about what you need to prepare for here.
DetailsEUDAMED is the European database for medical devices. However, it is not only used to manage medical devices. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. These regulations affect the work of manufacturers and also the work of authorities and notified bodies.
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