GAMETIME FOR NOTIFIED BODIES: This Sunday, the starting gun fires for the Continent’s notified bodies. (We never tire of using the relay race metaphor to describe implementing the EU’s new complex, multi-stage medical device regulations.) It’s the first day bodies can apply with national authorities to keep doing their job of assessing the quality and [...]
Team-NB welcomes a new member from Italy : Ente Certificazione Macchine Srl. (NB 1282). From now on, the association has 24 members from 12 different countries.
84% intended to submit their application in November, 8% in December and 8% next year.
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.
Article from Amanda Maxwell : A majority of notified bodies members of Team-NB, will submit their application to be designated following the new regulations, still at the end of 2017.
Françoise Schlemmer will be involved in training on the regulatory aspects of medical devices and more specifically on the impacts of the new European regulation.
She will address, inter alia, the implications of the new requirements for notified bodies on audits and will focus on major impacts for manufacturers.