Position paper on MDCG documents
19. August 2022 – The Medical Devices Coordination Group (MDCG) uses guidance to assist stakeholders in implementing the medical devices regulations. With this paper MedTech Europe provides its view on how guidance documents should be used in a way that does not disrupt manufacturers’ efforts to transition to the new rules of the MDR and IVDR. MedTech Europe will now share the paper with the European Commission, the MDCG, the Competent Authorities for Medical Devices (CAMD) and the Notified Bodies.
To view the full position paper, see here.