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.
Françoise Schlemmer made a presentation during the Open Session Conference of MedPharmPlast General Assembly which took place in Brussels.
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.
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 [...]
concerning the adoption of MD draft regulations by ENVI group TEAM-NB Press Release
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.
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 [...]