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.
Team-NB is extensively involved. Members are particularly diligent.
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.
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 reject the trilogue results. These amendments were rejected, which from a procedure point of view is a final endorsement of [...]
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.
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 [...]