Health Economic Evidence Requirements for Medical Devices in Europe (Report #13)

Medical devices are transforming healthcare by advancing diagnostics, enhancing patient outcomes, and optimizing costs. However, manufacturers face growing demands from payers, regulators, and healthcare providers for robust health economic evidence. By examining challenges and best practices, this paper aims to guide manufacturers in developing compelling, compliant submissions that meet the needs of diverse European markets.

This White Paper provides key insights into health economic evidence requirements across the BIG5 European markets: England, France, Germany, Italy and Spain. 

By exploring country-specific requirements and best practices, this guide empowers manufacturers to develop tailored, evidence-driven market access strategies that meet payer expectations and drive adoption across European healthcare systems.