RAC devices EU Exam with Complete Solutions

regulations - ANSWER-legally binding and directly enforceable directives - ANSWER-legally binding but just be transposed into national law each country can decide how they want to implement medical device directive (MDD) - ANSWER-directive 93/42/EEC includes essential requirements for safety but not technical specs where are technical specifications located? - ANSWER-standards 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) - ANSWER-directive 98/79/EC essential requirements - ANSWER-safety requirements that devices must meet outlined in MDD CE Mark - ANSWER-manufacturer can self certify for just devices must have technical file demonstrating conformity Clinical requirements to market - ANSWER-literature on safety and effectiveness and device shows equivalency to the ones in those studies clinical investigations Notified Bodies how they work - ANSWER-must be approved by counties national competent authority can only review the types of devices they are approved for notified bodies - what they do - ANSWER-assess compliance with requirements of EU device law