Back in October, the Medical Device Coordination Group (MDCG) published MDCG 2023-4, Medical Device Software (MDSW) – Hardware combinations, Guidance on MDSW intended to work in combination with hardware or hardware components.
According to the scope statement of the document, the guidance “intends to examine and provide clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors etc.) are a medical device or an accessory to a medical device. [It] also outlines scenarios where the hardware or hardware component incorporating a data collection element are not medical devices or accessories to a medical device.” mdi Europa will issue a dedicated article on that topic at a later stage.
Delegated Regulation (EU) 2023/2197 has been published in the Official Journal of the European Union on October 20. The regulation amends annex VI of the MDR. Manufacturers may now assign a Master UDI-DI for contact lenses of the same design parameters where previously individual UDI-DIs were required for different contact lens variants. The regulation enters into force the twentieth day after its publication. Manufacturers may already now follow the act and it becomes obligatory as of November 9, 2025.
Source: European Commission