MDCG Guidance on MDR/IVDR device sampling + MDR Codes

The MDCG published two important guidance documents this afternoon.

Firstly, an Explanatory note on MDR Codes, i.e. MDA/MDN, MDS, MDT was published. These Codes are used by the manufacturer when applying to the Notified Body (NB) for the assessment of its devices. The verification of the MDR Codes by the NB is performed in order to confirm that the NB has been indeed accredited for this specific code and has available resources to carry out the relevant conformity assessment activities (''feasibility evaluation'').

The full document can be found Oh! It looks like you do not have access to this page.
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