Based on the EU government, guidance documentation is not necessarily obligated to be followed by law. They are to provide clarity on directives based on standards. The council approves the directives but does not state how to enforce the law. The guidance documents are broken down into three components:
1. MEDDEV: written by the Competent Authority
2. NB-MED: written by notified bodies
3. Competent Authority Guidance Documents: specific to the competent authority of that country that writes it
Personally, the NB-MED guidance document seems to have more credibility out of all other guidance documents because they are written by the notified body. The notified body are the private companies that are contracted by the competent authority to audit and inspect the manufacturer. They would know the most details in terms of providing clarity on a derivative compared to the comparative authority. The MEDDEV guidance document does apply to the entire EU but the people writing it are not in direct contact with the manufacturers. The Competent Authorities get their information about the manufacturer through notified bodies.