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MEDICAL OR NOT MEDICAL? THAT IS THE QUESTION

Introduction The European Union has always given due consideration to the medical device market and its regulation. The reason for this attention is twofold: on the one hand, to ensure the quality of the devices on which our medical care relies, and on the other hand, to prevent excessive fragmentation of legislative approaches within the […]

EUDAMED: get ready for registration

There are more  than 500,000 types of medical devices in the European Union (EU) market. Their importance for the healthcare sector as a whole and for each individual patient cannot be underestimated. This competitive and innovative market is currently supported by a regulatory framework aimed at ensuring its smooth functioning. A key role in this […]