We have updated this white paper to reflect the latest developments surrounding planning and implementation of EU MDR/IVDR. Please click here for the update.
The European Union Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) is a set of standards that governs the production and distribution of medical devices in Europe. Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The regulation will establish a transparent, predictable and sustainable framework for medical devices to ensure a high level of health and safety.
But is the MDR on track for its implementation next year (2022 for IVDR)? The European Commission is seemingly only considering the direct components of the new regulatory scheme and not other key elements like notified bodies, harmonized standards and Eudamed.
Our new white paper examines how the shortage of notified bodies, in addition to system requirements, infrastructure and secondary legislation, could present a challenge for timely implementation of the MDR and IVDR.