Team-NB 15th anniversary took place at the Metropole Hotel
Please discover the press release : TEAM-NB-15Anniversary-PressRelease-20160411
Please discover the press release : TEAM-NB-15Anniversary-PressRelease-20160411
Namely : Team-NB-Working-Groups-Attendee
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 Industry association and from European Commission.
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 (Unique Device Identification - UDI) • Convergence of models for marketing submissions (Regulated Product Submission - RPS) Namely the possible [...]
The event is taking place in Brussels, at the Metropole hotel, on April 11th 2016. A panel of VIP guests is going to inform the participants on the state of the new regulations and a Walking dinner reception will follow.
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 full-time work and compromise.