New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR

The Medical Device Coordination Group (MDCG) has issued another guidance document. MDCG 2021-10 references certain principles and terminology used in appendices E – I of the IMDRF N48 guidance document on Unique Device Identification (UDI) systems.

The document states that there are principles and terminology that are not fully aligned with Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR). MDCG 2021-10 intends to provide clarity in that regard and includes a useful table that maps the concerned principles and terms.

Should you require the document, please don’t hesitate to get in touch. 

Source: European Commission

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