MDR & IVDR certification: where we are?
Info utili
During the webinar, regulatory updates regarding the registration process for medical devices (MDRs) and, specifically, in vitro medical devices (IVDR) will be discussed. The necessary steps to submit certification requests to notified bodies (NB) will be presented, along with effective strategies to meet the deadlines established by Regulation 2023/6047. An overview of the current European situation and the activities that a company must implement to certify medical device software will be provided.
Goal of the webinar
During the webinar will be discussed the regulatory framwork regarding IVDR and MDR, including recent updates and related criticalities. Experts from the sector will share their expertise, and the importance of manufacturers' compliance with the deadlines for sending requests for certification to notified entities and highlighted the necessary actions to be taken to meet the deadline set by Regulation 2023/607. Specifically, the webinar will focus on ''Active Medical Devices'' and the ongoing regulatory updates required to achieve certification for electrical safety and electromagnetic compatibility.
Useful information
Duration: 11:00 am - 12:00 pm
Delivery mode: online
Course language: italian
