A first group of Notified Bodies has signed the voluntary Code of Conduct for Medical Device Notified Bodies. The Code of Conduct is an initiative to improve harmonised implementation of the European directives, creating a more level playing field for manufacturers. The initiative of this NB Plus Group has received strong support from various stakeholders.
As a voluntary initiative the Code of Conduct aims at establishing a uniform basis for the assessment, surveillance and certification of medical device manufacturers and medical devices under the European directives MDD and AIMD. The General Statement and the General Principles specify criteria such as the qualification and experience of assessment personnel and the minimum time required for various conformity assessment processes.
The signatories of the Code of Conduct express the necessity of strict and uniform quality control of the Notified Bodies in the Medical Device sector. Through voluntary harmonisation, they support the European legislative framework on an operational level, to improve consistency of conformity assessment operation hence creating a more level playing field for manufacturers and increasing trust in the European regulatory system for medical devices.
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The NB Plus group includes:
After signing the Code of Conduct, the NB Plus Group commits itself to continuous improvement processes, especially the extension of the Code of Conduct to topics including clinical evaluation, IVD and Type Examination and the creation of a voluntary enforcement mechanism among the signatories. The NB Plus Group invites other Notified Bodies to join the Code of Conduct and to work together on further harmonisation. A copy of the Code of Conduct can be obtained from any of the participating Notified Bodies.
In 2009, BSI, DEKRA, LNE/G-MED, TÜV Rheinland and TÜV SÜD started an initiative to create a Code of Conduct for the operation of medical device Notified Bodies. This group – previously named NB5 – subsequently involved further Notified Bodies in the drafting process and sought view from other stakeholders.