Difference between US and EU market

Question

Accepted Answer

The US and EU markets differ in terms of regulatory requirements, market size, and product approval processes.

Regulatory requirements: The US FDA has its own set of regulations, while the EU follows the CE marking system.
Market size: The US market is larger in terms of population and GDP, offering greater potential for sales and revenue.
Product approval processes: The FDA requires pre-market approval for most medical devices, while the EU has a CE marking process based on conformity assessment.
Clinical data requirements: The US generally requires more extensive clinical data for product approval compared to the EU.
Reimbursement systems: The US has a complex reimbursement system involving insurance companies, while the EU has various national healthcare systems with different reimbursement processes.

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