Commission's Go-Live Date For New Eudamed Medical Device Database: Will It Actually Be Met?
Executive Summary
Many questions surrounding compliance with the data submission requirements under the new Eudamed database remain outstanding. How should companies plan their submissions in the face of these uncertainties? And will the database even be ready on time, or will it be subject to a delay of up to six months?
You may also be interested in...
Eudamed - A Moving Target But On Track For March 2020 Partial Go-Live
While Eudamed is largely on track, there could be a few months of delay in the availability of certain critical parts of the EU's updated medical device database. Stakeholders are working toward a May 26, 2020, deadline for the full application of the EU Medical Devices Regulation, including Eudamed.
10 EU-Based Key Medtech Opinion Leaders React To The 'Implant Files'
Nov. 25 was the halfway mark in the three-year transition toward full implementation of the new EU Medical Devices Regulation. It was also the day the International Consortium of Investigative Journalists (ICIJ) dropped a bomb on the medical device sector, and it has been shelling the industry every day since. How are key industry experts reacting?
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.