He advised companies to try to turn to notified bodies that have a good track record and good capacity to take on new work, and for instance consider looking at those that are adhering to the TEAM-NB code of conduct.
The meeting is held in two parts. The first part is a meeting with representatives of Notified Bodies only and the second part of the meeting will take place with representatives of Notified Bodies, of [...]
The objective is to promote regulatory convergence in the medical devices sector. This could cover: • Recognition of manufacturers' quality management systems (QMS) audits • Convergence of systems for identifying and tracing medical devices [...]
Giovanni La Via, Chair of the Committee, confirmed the target to reach a compromise by July 2016. He however warned that the topics such as scrutiny, genetic testing, liability insurance and clinical trials would require [...]