Per my personal experience, the current company I worked for used the same approach in receiving approval by the EU and obtaining the CE Mark before getting FDA approval. In general I believe it was easier because the device that my company is working is a Point of Care Diagnostic Testing device which would fall under the IVD Directive 98/79/EC and hence its classification would either be a List A or List B. This classification would be based off of the Essential Requirements Checklist. Whereas, when going through the 510k process for a Class II medical device with PMA for the FDA, clinical data must also be presented, as well as a means of showing efficacy, which I believe is the major difference between the FDA and EU. The FDA puts a strong emphasis on efficacy whereas the EU looks at the risk.