01
/ Question/
Can existing test reports be used to cover new model registration changes for in vitro diagnostic instruments?
02
/ Answer/
Provided that the new model can be considered as part of the same registration unit, the company should assess the representativeness of the performance of the existing model. If there are differences in performance indicators for the new model, testing should be conducted for the differing aspects. However, regarding the representativeness of electromagnetic compatibility requirements, this should be clarified by a medical device testing institution, or separate testing should be conducted for the new model.
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