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MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR)…

May 26, 2022, marks the start of the 5-year staggered implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746). Unlike…

The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each day, we advance…

We all know and love (ahem) the EU MDR (2017/745). And although it is defined as the EU Medical Device Regulation, it…

You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants…

By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very…

The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot…

Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices…