What are the main changes compared to the previous Directive 98/79/EC?

With the IVDR 2017/746 the criterion for classifying IVDs is redefined since it is no longer based on a list of devices, but on seven rules: there are now four classes, from the lowest risk (A) to the highest risk (D), which are established according to the intended use and the measurement of analytical data.

Other changes mainly concern the procedures for defining conformity and the criteria for evaluating the device performance.

Further changes affect the post-market surveillance level and traceability of product safety.

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