Based on this weeks lecture the EU regulatory focuses on risk and essential requirements checklist. The FDA analyzes more so on efficacy and the FDA makes the sole decision on if the medical device meets the regulations. EU regulatory is split into:
1. Competent Authority: Similar to the FDA but each country has their own Competent Authority. Unlike the FDA the Competent Authority does not complete audits or inspections. The Competent Authority proposes rules for the EU to vote on. Their main priority is analyzing the risk of the medical device.
2. Manufacturer: They make the medical device and hold the final responsibility of the device.
3. Notified Body: These are private companies that are contracted by the EU to inspect and audit manufacturers for the Competent Authority.
Competent Authority knows that the manufacturer of the medical device meets the audit and inspection criteria based on the CE mark placed on medical devices. If it is approved in one country, then it is approved in all European countries. That is not how the FDA works. The FDA has the right to audit and inspect manufacturers directly. The FDA does not base their decisions solely on risk or an essential requirements checklist. The regulatory pathway of the FDA is much more picky and specific in terms of classification and design controls. Therefore, I would agree with many of my peers that a medical device is easier to have approved in the EU then USA because of the FDA regulatory breakdown.