Research Methods in Medicine & Health Sciences
Quantifying the state of the art: A random appraisal-weighted method for clinical evaluation under EU MDR
Background The European Union Medical Device Regulation (EU MDR) requires manufacturers to establish quantitative, state of the art parameters for clinical evaluation. Because most available evidence is heterogeneous and uncontrolled, conventional meta-analytic methods provide limited support for deriving device level benchmarks. Methods A methodological framework was developed using synthetic datasets reflecting typical real-world evidence. Study means, variances and standard errors were combined using fixed effec …