EU IVDR Implementation Workshop

The new EU In Vitro Diagnostics Regulation will profoundly affect the IVD market in Europe. A new risk-based classification system, stricter postmarket surveillance, upgraded dossiers for all products and notified body review of previously self-declared products, greater clinical evidence requirements, and novel emphasis on transparency and traceability, including reporting of risk, clinical, safety, and performance data to a publicly available database will require massive investments of time and money as well as significant changes in organizational structure. The transition period may seem long, but consultants and the dwindling number of notified bodies are already swamped with EU MDR implementation. Help will be hard to find. Planning should start now. Registration will open soon.