Month: October 2023

EU Parliament

EU Unveils UDI System for Contact Lenses

The European Commission has recently issued Delegated Regulation 2023/2197 which outlines the assignment of unique device identifiers (UDIs) for contact lenses, with the slated implementation date set for 9 November 2025. Contact lenses are considered as “highly individualized devices” which would force their manufacturers to register a disproportionate amount of UDIs for the same product. …

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EU Parliament

MDCG 2023-4: Navigating the Intersection of Software and Hardware

The landscape of medical devices is evolving rapidly, with an estimated one in four devices incorporating or being medical device software (MDSW). This surge is driven by the integration of smart technology, from smartphones to wearable devices, transforming healthcare interactions for patients and clinicians alike. Crucially, many MDSW solutions rely on hardware components like sensors …

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EU Parliament

Borderline Manual Update

The manual on borderline and classification has been updated to version 3 and covers the following new product types: You may access version 3, here.