Medical Device Compliance Under MDR: Separating Regulatory Reality from Common Misconceptions

The EU's Medical Device Regulation (MDR) has raised compliance stakes significantly, but many device teams are still treating it as a documentation exercise rather than substantive clinical evidence and post-market accountability. Common pitfalls—oversimplifying equivalence claims, confusing clinical trial volume with appropriate evidence, or assuming harmonized standards ensure automatic compliance—create vulnerability to notified body rejections. Success requires understanding what regulators actually scrutinize, not just what looks good on paper.