On the 21st of May, a new revision of the guidance on medical devices for applicants, marketing authorisation holders and notified bodies has been published. This document provides regulatory and procedural guidance on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices based on experience gained since the implementation of the new regulations and actual cases.

Source: Medical devices: new guidance for industry and notified bodies | European Medicines Agency (

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