RAC devices EU Exam with Complete Solutions 100% SOLVED

RAC devices EU Exam with Complete Solutions 100% SOLVED regulations - ANSlegally binding and directly enforceable directives - ANSlegally binding but just be transposed into national law each country can decide how they want to implement medical device directive (MDD) - ANSdirective 93/42/EEC includes essential requirements for safety but not technical specs where are technical specifications located? - ANSstandards products manufactured in line with standards are assumed to meet essential requirements list of harmonized standards punished in the official journal in vitro diagnostoc device directive (IVDD) - ANSdirective 98/79/EC essential requirements - ANSsafety requirements that devices must meet outlined in MDD CE Mark - ANSmanufacturer can self certify for just devices must have technical file demonstrati