Italy | Medical devices, actions to facilitate the transition to the new Regulations and avoid shortages of medical devices

The Medical Device Coordination Group in the meeting of 24-25 August 2022 approved the document MDCG 2022-14 MDCG Position Paper Transition to the MDR and IVDR Notified body capacity and availability of medical devices and IVDs , which indicates a series of specific actions to increase the capacity of Notified Bodies, allow companies to access Notified Bodies and promote the preparation of manufacturers in order to facilitate the transition to Regulations (EU) 2017/745 and 2017/746 and avoid the shortage of medical devices.

The document responds to the need to ensure the presence on the market of safe medical devices capable of providing high performance, simplifying procedures while maintaining rigor in the purpose.