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Article in Politico by Sarah Wheaton

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 [...]

By |November 29th, 2017|news|0 Comments

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.

By |November 14th, 2017|news|0 Comments

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.        

By |November 8th, 2017|news|0 Comments

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.

By |September 5th, 2017|news|0 Comments

Extraordinary General Assembly of the association will take place in Brussels, at the NH Collection Grand Sablon.

By |September 5th, 2017|news|0 Comments

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

By |September 4th, 2017|news|0 Comments

Politico Article : Medical devices regulations need action to begin relay race

http://www.politico.eu/article/medical-devices-start-their-relay-race/

By |September 4th, 2017|news|0 Comments

Françoise Schlemmer attended a conference on notified bodies views on the MDR at the MEDPHARMPLAST workshop

By |August 29th, 2017|news|0 Comments

New regulations , phase 2 interpretation working groups meeting in Frankfurt

By |May 16th, 2017|news|0 Comments

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.

By |May 8th, 2017|news|0 Comments