In most cases, Class A devices can be self-certified, unless they are sold sterile, while for Class B, C and D devices it shall be required a conformity evaluation by a Notified Body designated according to the IVDR (EU) 2017/746. It is important to underline that the 90% of IVDs, for which the “self-certification” modality is currently in place, shall be re-certified according to the IVDR Regulation.

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