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  • asimbana replied to the topic Guidance Documents in the forum EU Regulatory Basics 7 years, 3 months ago

    Essentially MEDDEV, NB-MED, and Competent Authority Guidance Documents all have their uses and advantages. However, considering the process of NB-MED bring written by notified bodies and MEDDEV written by competent authorities and lastly competent authority guidance documents written by individual CA’s, NB-MED would be the most useful. NB-MED has its uses in providing clarification and lead companies into the correct path to follow directives or regulation in the EU, guidance documents is not mandatory but it is essential to have and follow and save companies time and money to avoid mistakes. In regards on how NB-DEV is useful, its because they are written by the the notified bodies, these have the power to inspect manufacturers, pass or fail a device based on audits and pass or fail when it comes to obtaining a CE Mark which is required to gain approval, which the CA’s use as best judgement of the notified bodies.