Market access for Medical Devices and In Vitro Diagnostics in Europe

Market access for medical devices and in vitro diagnostics (IVDs) in Europe presents unique challenges and opportunities. Here are some key considerations:

Manufacturers must demonstrate compliance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). Upon obtaining the CE Certificate, manufacturers must prioritize Post-Market Surveillance (PMS) and Vigilance, including Post-Market Follow-up activities, to proactively collect and evaluate clinical evidence data.

Navigating reimbursement systems across European member states is essential to ensure eligibility for reimbursement under national healthcare systems. This may involve demonstrating the clinical and economic value of the device through health technology assessments (HTAs) and negotiating with payers. A strategic analysis, beginning with a gap analysis to assess evidence sufficiency for reimbursement and HTA approval, is crucial. Developing an overarching reimbursement strategy encompassing coding, payment mechanisms, reimbursement tariffs, policies, and HTA considerations is vital.