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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 the Industry association and from European Commission.

By |February 27th, 2017|news|0 Comments

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

By |February 27th, 2017|news|0 Comments

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.

By |February 26th, 2017|news|0 Comments

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 Notified Bodies. The seminar took place at the Pullman Hotel in Brüssel and was concluded with a panel discussion. On [...]

By |February 26th, 2017|news|0 Comments

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

By |February 25th, 2017|news|0 Comments

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

By |February 22nd, 2017|news|0 Comments

MedpharmPlast Europe GA

Françoise Schlemmer made a presentation during the Open Session Conference of MedPharmPlast General Assembly which took place in Brussels.

By |November 30th, 2016|news|0 Comments

Beginning of the 2nd phase of the work concerning the interpretation of MDR requirements with the members of the MDR Working Group in Brussels.

By |October 18th, 2016|news|0 Comments

General assembly meeting

On October 11th general assembly meeting, Team-NB decided to suspend the audits against the Code of Conduct in order to work on the preparation of interpretations on MDR requirements in an objective of harmonisation.

By |October 13th, 2016|news|0 Comments

In the framework of the new Medical Device Regulations,

you will find below the Team-NB members’ intention to submit their application to be designated against MDR and/or IVDR. The Team-NB notified body members have a double advantage to pass their designation audit :   The peer review against the Code of Conduct which requirements are ahead of the today ones. The working groups reviewing [...]

By |July 18th, 2016|news|0 Comments