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MDCG 2021-14 - Explanatory note on IVDR codes - European Commission

European Commission’s Medical Device Coordination Group (MDCG) released a new document on 13-July-2021, detailing the use of codes under the In Vitro Diagnostic Regulation (IVDR).

This guidance is intended to explain the different levels of codes and how they should be used, including the use of conditions to ensure a harmonized use of the codes especially for the allocation of resources to conformity assessment activities.

These lists of codes should be used in a way that allows a multi-dimensional application to all typology of devices. This will ensure that NB as well as the personnel assigned to conformity assessment are fully competent for the devices they are required to assess.

The lists of codes and corresponding types of in vitro diagnostic medical devices (IVD) can be characterized by design and intended purpose including companion diagnostics devices, devices for self-testing or for near-patient testing, as well as by manufacturing processes and technologies used, such as sterilization.

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