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hm243 replied to the topic Guidance Documents in the forum EU Regulatory Basics 7 years, 12 months ago
All three documents are important in their own way in ensuring the safety of medical devices. As a result of the MEDDEV Guidance Documents and Competent Authority Guidance Documents being written by the Competent Authorities, they do not have the authority to approve medical devices. They also cannot audit or inspect, but are able to take a product off the market if they have a reasonable argument as to why. The NB-MED Guidance Documents are written by the Notified Bodies, so they have more power in approving medical devices. This seems to be the most useful in making sure a device goes through the regulation process in the EU. These documents are written by a group who has the option to inspect manufacturers as they seem fit. In addition, they have the ability to audit which can result in a medical device passing or failing in the market. Once a device is marked as a failure, it prevents the device from further being sold in EU. Of all three documents, the NB-MED Guidance Documents has the most significance in regulating a device.