55th NB-Med meeting will take place on 11 and 12th October.
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.
ENVI Committee of the European Parliament confirmed agreement on medical device and IVD regulations.
The texts can be downloaded and viewed on the European Parliament website.
Medical devices : deal reached on new EU rules
The political agreement reached is still subject to the approvals (Council's Permanent Representatives Committee and Parliament's ENVI committee). The agreed two draft regulations are expected to achieve a twofold aim : making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in [...]
Article in Scrip Regulatory Affair by Vibha Sharma
Stricter Equivalency Requirements
A new Team-NB Administrative Committee was elected during the General Assembly meeting.
Pease find below the press release : TEAM-NB-PressRelease-20160413
Erik Hansson, deputy head of the unit responsible for medical devices within the European Commission’s Directorate General Grow, told during Team-NB 15th Anniversary meeting.
He advised companies to try to turn to notified bodies that have a good track record and good capacity to take on new work, and for instance consider looking at those that are adhering to the TEAM-NB code of conduct.