Europe – MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices

The MDCG hereby endorses the principles laid out under Appendixes E – I of the IMDRF
N48 guidance document, as published on 21 March 2019 on the IMDRF website.
For ease of readability, this document intends to provide clarifications as to how certain
principles and examples outlined in N48 Appendixes E-I apply under the MDR/IVDR. The
examples provided within the Appendixes are for informative purposes and should not be
interpreted as the sole manner for complying with UDI obligations.
It is recommended that these documents are always read in conjunction with Regulation
(EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro
diagnostic medical devices (IVDR) and to take into consideration the respective issuing entity
rules.
Certain principles and terminology set out within the IMDRF N48 Appendices are not
applicable under the MDR/IVDR. The following comparison table explains the
applicable MDR/IVDR principles and terminology that should be applied for
compliance and is non-exhaustive in its nature. Please note that ‘X’ in the table below
indicates that this IMDRF principle/terminology is not applicable under either the MDR
and/or IVDR…