Medical Device Regulation in the EU

Medical Device Regulation in the EU

Set to come into force this May, the updated EU Medical Device Regulation (MDR) will see manufacturers of medical devices and healthcare equipment, adhering to more stringent standards throughout a product’s lifecycle.

The aim is to improve patient safety across one of the world’s largest markets for medical devices, which accounts for an approximate €110 billion in annual sales.

Particular attention has been paid to IoT medical equipment and products that have programmable electronic software. Devices destined for the European marketplace will now have to undergo approval through a risk classification system that puts onus of cybersecurity predominately on the manufacturer.

Read more here.

About the author

Dr. Mariana Damova is the CEO of Mozaika, a company providing research and solutions in the field of data science, reasoning with natural language semantics, and natural human computer interfaces, creativity enhancing applications, and research infrastructures for the humanities. Previously, she was a Business development Manager and a Knowledge Management Expert specializing in ontology engineering and linked data management at a world leading technology provider. She was instrumental in the successful winning and knowledge modelling of large data integration and management projects such as the Semantic Knowledge Base for The National Archive of the United Kingdom and Research Space for the British Museum, as well as European FP7 projects such as Europeana Creative and Multisensor. Her work focuses on the design and development of data integration infrastructures which allow efficient querying, access and navigation over linked data. She has managed the building of the official experimental Europeana SPARQL endpoint holding Europeana semantic data. Mariana holds a PhD from the University of Stuttgart and teaches semantic technologies and multimedia at the New Bulgarian University in Sofia. She regularly reviews books and articles for ACM and has authored books and scientific articles in linguistics and semantic technologies. She has successfully lead international interdisciplinary teams and projects carrying technological risks, driven and managed change in engineering and operational contexts in North America and in Europe, and acquired the ability to leverage marketing requirements with knowledge intense technological solutions.

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