Common Specifications – Competing with standards?
Both the MDR and IVDR introduce the concept of Common Specifications. Definition of Common Specifications MDR and IVDR define Common Specifications as follows: Purpose of Common Specifications EU Directives, such as the MDD and IVDD, as well as EU Regulations, such as the MDR and IVDR impose so-called general requirements on all medical devices must meet. If the requirements are not met, manufacturers must not…
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