The work of Notified Bodies (“NBs”) in the conformity assessment and certification of medical devices is a key cornerstone of the EU legislative system to safeguard public health. Established in the early 1990s to replace the nationally existing systems in the European member states, the legal framework follows the principles of the New Approach Directives to ensure the safety of medical devices on the European market and contribute to public health. Since its adoption several changes took effect such as the increased number of member states. Also new and more complex technologies have been introduced. Now, 11 notified bodies for the certification of medical devices have signed a voluntary code of conduct. Their main aim is the further harmonisation of the requirements for European manufacturers of medical devices. The code of conduct can be downloaded from the BVMed Website.
Although adoption of the code of conduct is voluntary to notified bodies at this time, it gives a clear signal that signatory notified bodies declare to be fully aware of their responsibility to ensure that certification of medical devices complies with the directives. Any party with recognised notified body status is entitled to sign up to the code of conduct.Yvonne Klöpping