Manual on borderline and classification under Regulations (EU) 46 v2īackground note on the use of the Manual on borderline and classification for medical devices under the Directives. Ongoing guidance documents Borderline and Classification Reference They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation. The documents on this page are not legally binding. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number-revision”. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices.
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