Unclear proposal from the EU Commission on how to solve the MDR challenges


Even before the EU regulation on medical devices (MDR) came into force, medical technology companies and doctors were concerned that it would endanger the availability of medical devices in the EU. Unfortunately, the fears have come true. Above all, notified bodies have a limited capacity following the stricter requirements since the MDR came into force. … Continue reading Unclear proposal from the EU Commission on how to solve the MDR challenges

IVD manufacturer – use the progressive roll-out of IVDR in a smart way


The countdown has started. On 26th of May the In Vitro Diagnostic Regulation, also known as IVDR, is entering into force. The aim of the regulation is to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic devices (IVDs), which ensures a high level of safety and health whilst supporting innovation. … Continue reading IVD manufacturer – use the progressive roll-out of IVDR in a smart way