New member
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.
Team-NB has collected information from members about their re-application.
84% intended to submit their application in November, 8% in December and 8% next year.
57th NB-Med meeting is planned on 10 and 11th October in Brussels.
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.
https://medtech.pharmamedtechbi.com/MT121489/Notified-Bodies-Apply-For-EU-MDRIVDR-Designations-Despite-Document-Shortfall
Politico Article : Medical devices regulations need action to begin relay race
http://www.politico.eu/article/medical-devices-start-their-relay-race/
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.
For the 7th time, Team-NB has run a survey among its members to analyse the certificates being issued, trying to differentiate between various directives and types of certificates.
The results of the 2016 survey and the comparisons with the formers survey, are available in the document named Team-NB sector survey in 2016 on our web site.