The Medical Device Coordination Group (MDCG), part of the European Commission, has provided a guidance document navigating the use of codes under the In Vitro Diagnostic Regulation (IVDR). The codes are used to describe the qualifications of both the notified body staff members and the qualifications required for assessing the devices. The codes also describe the extent of the notified body’s designation, and “is intended to explain the different levels of codes and how they should be used, including the use of conditions to ensure a harmonised use of the codes especially for the allocation of resources to conformity assessment activities.”
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