A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices.
Products that combine a medicinal product (or substance) and a medical device are regulated either under the pharmaceutical framework or the medical device framework, depending on their main mode of action. The revision is based on the experience gained since the implementation of the new regulations and actual cases encountered. The document covers regulatory and procedural guidance for…
