Global Regulatory Considerations (FDA and EU MDR/IVDR)

Global regulatory development requires understanding how regulatory expectations differ across regions. FDA and European regulatory frameworks share common goals but vary significantly in evidence requirements, timelines, and post-market obligations.

Organizations planning global development programs often evaluate regulatory differences early to inform development strategy, sequencing, and resource planning. Misalignment between regional requirements can result in rework, delays, or increased regulatory risk.

A global regulatory perspective supports more efficient planning and informed decision-making.

Key Differences Between FDA and EU Regulatory Frameworks

While both FDA and EU authorities emphasize patient safety and product performance, regulatory approaches see meaningful differences.

Common areas of divergence include:

• Clinical and performance evidence expectations

• Classification and conformity assessment pathways

• Post-market surveillance and vigilance requirements

• Regulatory timelines and authority interactions

Understanding these differences is essential when coordinating multi-region development programs.

Strategic Implications for Development Planning

Global regulatory considerations often influence:

• Clinical study design and endpoint selection

• Evidence generation strategy

• Launch sequencing and market prioritization

• Resource and budget planning

Early alignment reduces the risk of duplicative studies or regulatory delays.

When Global Regulatory Expertise Is Needed

Organizations typically evaluate global regulatory considerations during:

• Early development planning

• Expansion into new regions

• Legacy product remediation assessments

• Portfolio and lifecycle strategy reviews

Even companies initially focused on a single region often assess global regulatory implications to inform long-term planning.