The Medical Device Coordination Group (MDCG) published yesterday a new document that provides a comprehensive review of questions related to the combination of medical hardware and software systems, specifically focusing on the application of Article 22 of the MDR to these systems.
The document contains, therefore, valuable insights and guidelines toward the development and assessment of medical hardware and software combinations that need to be taken into account.
To read the complete document, have a look here: MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations
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