Hi all,

From my limited experience, it is indeed a lot easier to obtain EU approval prior to US approval. The main reason in my opinion is that in EU the manufacturer is not dealing directly with the regulatory agency. The manufacturer is dealing with a notified body which is contracted to review the on behalf of the EU competent authority. There are so many Notified bodies available in the market who are competing for business since they charge manufacturers with substantial fees to review the technical dossier. This allows for a faster review process and more collaborative work. On the other hand, As andrew have mentioned, the EU regulations contains checklists and do not leave much room for manufacturers’ interpretation. The FDA reviewers are the sole decision makers for the interpretation of the regulations.

– Fady Khalla