Eleven Notified Bodies signed Code of Conduct

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.

To read more on the topic please visit: http://www.tuvps.co.uk/home-psuk/company/tuev-news/eleven-notified-bodies-signed-code-of-conduct

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