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