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May 2017

April 2017

NBs attendance to NB-Med meetings

Team-NB is extensively involved. Members are particularly diligent.

February 2017

56th NB-Med meeting will take place on 11 and 12th April.

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 [...]

General Assembly of the association will take place at the NH Collection Grand Sablon on April 11th 2017.

European Parliament adopts formally the two texts MDR and IVD

The Plenary session of the European Parliament just adopted the two texts on Medical Devices and In Vitro. There were for each text only one amendment tabled by Nigel Farage and the UKIP, asking to [...]

ENVI committee tabled a recommendation for debate and vote in plenary session of the European Parliament.

This 2nd reading is scheduled on March 4th, 2017.  

NB-MED Chair and vice-president Hans-Heiner Junker attended the Meeting of the Regulatory Affairs Committee meeting of Medtech Europe.

He presented the concerns Notified Bodies have on the implementation of the new regulations. During an extensive round of discussion various obstacles and unclear requirements and possible options to overcome such interesting challenges were discussed.

Vice-president Hans-Heiner Junker attended a seminar organized by EUROMCONTACT for their members.

The topic of the entire day was the implementation of the new MDR and the impact to their members.   Hans-Heiner Junker provided a speech on two topics: Impact on Technical Documentation and Impact on [...]

Françoise Schlemmer will make a presentation in the Afipa meeting which will take place in Paris

Article in Medtech Insight by Amanda Maxwell : EU Notified Bodies Prepare For En Masse Redesignation

EU Notified Bodies Prepare For En Masse Redesignation-Medtech Insight-20170221