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Survey on applications by the Team-NB member notified bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD.

Team-NB-Press-Release-Applications-Survey-20180214

By |February 15th, 2018|news|0 Comments

Team-NB participates at the international workshop on global use and application UDI.

By |February 12th, 2018|news|0 Comments

MedTech forum : Team-NB members answered the questions of the audience in the session: “What’s happening with Notified Bodies?”.

By |January 25th, 2018|news|0 Comments

The CAMD (Competent Authorities for Medical Devices) published on their web site 2 documents related to FAQs to the transitional provisions of MDR and IVDR.

http://www.camd-europe.eu/media-centre

By |January 24th, 2018|news|0 Comments

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