The EU Medical Device Regulation — effective for new device approvals since May 2021 and requiring legacy device recertification by 2027-2028 — has imposed the most significant increase in regulatory burden on the European medical device market in a generation. Notified Body capacity constraints, the EUDAMED database requirements, and the new clinical evidence standards have created significant compliance cost and market access delay for orthopedic device companies operating in Europe.
Topics Covered
• EU MDR Requirements and Timeline
• Notified Body Landscape
• Clinical Evidence Requirements Under MDR
• EUDAMED Implementation
• Japan PMDA
• China NMPA
• Global Regulatory Strategy and Submission Sequencing
Table of Contents
1. Executive Summary
2. Landscape Overview
3. EU MDR Requirements and Timeline
4. Notified Body Landscape
5. Clinical Evidence Requirements Under MDR
6. EUDAMED Implementation
7. Japan PMDA
8. China NMPA
9. Global Regulatory Strategy and Submission Sequencing
10. Strategic Conclusions and Recommendations
11. Appendix
List of Tables
Table 1. Overview and Key Data 2025
Table 2-8. Topic-Specific Analysis Tables
Table 2. Leading Suppliers — Strategy Assessment 2025
Table 3. Key Risks and Mitigation Strategies
Companies Profiled
Aesculap
Arthrex
DePuy Synthes
Enovis
Globus Medical
NuVasive
Smith & Nephew
Stryker
Wright Medical
Zimmer Biomet
