Hi Andrew,

I have always used Guidance documents to get better clarification on what the regulation is actually looking for. More specifically, I have used multiple MEDDEV guidance documents to make sure that I am following the right path when I am somewhat lost about what should be done. Guidance documents contain non binding roles. As Dr. Simon have mentioned, Guidance document show you a way to achieve compliance but they do not show you the way to compliance. I agree that NB-MED guidance documents may seem to carry the most weight, but remember notified bodies tend usually to follow local jurisdictions of where their headquarters are located. This might mean that they might add more regulations that what is required by the competent authorities. Therefore, I usually look into the MEDDEV first then follow the NB-MED.

Looking forward to see what others think,
Fady